Devices, systems, and methods for non-invasive chronic pain therapy

ABSTRACT

Presented herein are devices and systems as well as the methods of using the same for the purpose of reducing and/or ameliorating the sensation of pain, specifically, chronic pain. Particularly, in one aspect, the devices, systems, and their methods of use disclosed herein are effective for reducing peripheral nerve pain, such as resulting from traumatic nerve injury and other types of nerve damage.

CROSS REFERENCE TO RELATED APPLICATION

The present application claims the benefit of U.S. Provisional PatentApplication No. 62/609,330, filed Dec. 21, 2017 entitled “Systems andMethods for Non-Invasive Chronic Pain Therapy”, the disclosure of whichis incorporated herein by reference in its entirety

FIELD OF THE DISCLOSURE

The present disclosure relates generally to the treatment, alleviation,and management of pain. Devices and systems as well as their methods ofuse are disclosed herein for the treatment, alleviation, and managementof chronic pain in a manner that is less invasive, more effective forpain amelioration, and safer to use than traditional methods of painrelief. Particularly, the present disclosure is directed to providingnon-invasive therapy for chronic pain.

BACKGROUND OF THE DISCLOSURE

There are many different manifestations of pain. Pain can bepsychological, such as caused by depression and stress, or bodily, suchas due to a physical perturbation of a part of the body. In particularinstances, bodily pain may be caused by direct engagement of the bodywith physical objects in the world. These types of acute pain are wellknown, and have been widely treated. Specifically, bodily pain is mostoften treated by the administration of an analgesic, such asacetaminophen. Additionally, non-steroidal anti-inflammatory drugs, likeaspirin or ibuprofen, may be used to alleviate the sensation of painand/or reduce inflammation.

However, in various instances, such as in extreme pain duringpost-surgery recovery, non-opioid analgesics may not be sufficient tobring about an alleviation in the experience of pain. In such aninstance, opioid-based drugs like codeine or morphine and the like, maybe administered. Nonetheless, because of the highly addictive nature ofthese drugs their use is highly regulated. Despite these ever increasinglimiting regulations, opioid abuse remains a national epidemic thatcontinues to claim the lives of tens of thousands of people every year.Particularly, it is estimated that in 2017 opioid abuse claimed thelives of about 72,000 sufferers nation wide.

Thus, when experiencing acute pain, a sufferer has very limited optionsfor pain remediation. They can use an analgesic, such as acetaminophenor an NSAID, which may not be strong enough to relieve acute pain, orthey may use an opioid, and risk the possibility of becoming addicted.In either instance, neither medicament is a good option when faced withchronic pain.

It has been found that chronic pain is physiologically different fromacute pain. Specifically, acute pain is typically of sudden onset,usually the result of clearly defined underlying causes, such as bodilyinjury. Hence, healing the underlying cause typically resolves the painaltogether. In such instances, analgesics are administered as a stopgapfor ameliorating the sensation of pain until the underlying injury canbe healed.

Chronic pain, on the other hand, is different from acute pain. Incertain instances, chronic pain can be provoked by an injury that causesinflammation whereby cells at the site of the injury release a varietyof biochemical mediators such as prostaglandins, cytokines, e.g., TNFα,IL-1β, IL-6; chemokines, e.g., CCL2, CXCL1, CXCL5; growth factors, e.g.,NGF, BDNF; and neuropeptides, such as substance P and CGRP. The releaseof these injury release factors mediate a cascade of physiologicalresponses that evoke a pathway of pain that persist over time therebybecoming chronic.

Particularly, in particular instances, the injury is to nerve cellsthereby initiating a pain pathway that often times generate pain signalsthat travel from the peripheral to the central nervous system. Thesepain signals are not easily resolved by the administration of typicalpain medicines. More particularly, in either instance, once released,these pain mediators bind to and activate peripheral sensory nerves,which nerves then transmit pain messages to the Central Nervous System(CNS). When pain is acute, this signaling pathway is either notinitiated, in the same manner or to the same extent, and/or isrelatively easily resolved, as discussed above. However, when such painis not easily resolved, e.g., due to the release of adverse biochemicalmediators, it becomes chronic, which in turn may result in biochemicalchanges that affect long term alterations in the nervous system, andthereby cause a persistent increase in the number and intensity of painsignal transmission, e.g., peripheral and/or central sensitization.

Accordingly, injuries that adversely affect the peripheral nervoussystem, such as peripheral nerve injury, often results in thedevelopment of chronic intractable pain. As indicated, those sufferingfrom such chronic pain often prove unresponsive to typical, conservativepain management techniques. In such instances, Peripheral NerveStimulation (PNS) has been proposed for therapeutic resolution of pain.For instance, Melzack-Wall have proposed a gate control theory of painthat evidences a modicum of pain relief, but is limited to thosesituations where the pain is the result of injury to the PNS, and thespecific nerve being the source of the pain is clearly known anddistinguishable. It was neither useful for pain of unknown origins, norfor targeted administration of treatments. Likewise, Sweet and Wespicused electrical stimulation of peripheral nerves in the 1960s, whichresulted in a masking of pain sensations with a perception of tingling(paresthesia) that was caused by the electrical stimulation. However,electrical stimulation of nerves in and of itself can be painful,especially with respect to the stimulation of A-β nerve fibers.Subsequent refinements in the technology, surgical techniques, andpatient selection have led to some improved long-term results, but theseprocedures are invasive and/or are not generally applicable.

In addition to the use of electrical stimulation for the treatment ofthe sensation of bodily pain, the use of electrical stimulation for thetreatment of emotional pain, attendant to psychiatric disorders, hasalso been proposed. Particularly, efforts have been made to treatpsychiatric disorders with peripheral/cranial nerve stimulation. Forinstance, U.S. Pat. No. 5,299,569 discloses that some partial benefitshave been experienced with respect to pain relief by electricallystimulating the vagus nerve. U.S. Pat. No. 5,470,846, discloses anotherexample of treating emotional pain by electrical stimulation, in thisinstance depression, by the use of transcranial pulsing of a magneticfield. Yet further, U.S. Pat. No. 5,263,480, asserts that stimulation ofthe vagus nerve may be beneficial for the treatment of depression andcompulsive eating disorders. Furthermore, U.S. Pat. No. 5,540,734discloses the stimulation of the trigeminal and glossopharyngeal nervesfor the treatment of depression as well as other various psychiatricillnesses. Further still, U.S. Pat. No. 6,505,075 discloses peripheralnerve stimulations of the C2 dermatome area of the eye so as to treatintractable headaches that originate in the back of the head in the C2dermatome area. This method of delivering electrical stimulation energyto the C2 dermatome area involves positioning stimulation electrodes inthe fascia and subcutaneous regions proximate the C2 dermatome. Furtherresearch has shown that electrical stimulation may be used for treatingneurological diseases, including such disorders as Parkinson's disease,essential tremor, dystonia, and chronic pain.

Accordingly, in view of the above, in very limited circumstances,electrical stimulation may at times be advantageous for treatingneuro-related maladies. This is significant because typical methods fortreatment of such disorders often involve performing one or more lesionsin the neural tissue, which thereby destroys the nervous system tissuein an attempt to modulate neuronal activity. Particularly, for manyforms of intractable pain, e.g., occipital pain, traumatic brain injury,etc., which have proven to be resistant to analgesic medications,traditional treatment options typically involve chemical, thermal, orsurgical ablation procedures as a way of reducing the sensation of pain.For instance, surgical procedures for treating intractable pain includeneurolysis and/or nerve sectioning.

However, in various alternative instances, it has been determined thatdirect electrical stimulation is useful for modulating target neuralstructures without resulting in the destruction of nervous tissue. Themethods for using such electrical stimulation include electroconvulsivetherapy (ECT), transcranial direct current stimulation (tDCS) and vagalnerve stimulation (VNS). Specifically, a procedure for producingindirect brain electrical stimulation can be achieved via transcranialmagnetic stimulation. For example, transcranial magnetic stimulation(TMS) provides a non-invasive method for activating the human motorcortex such as for assessing the integrity of the central motorpathways. TMS is based on the principle of electromagnetic inductions.It has been determined that if rapidly changing magnetic pulses aregenerated and directed toward the skull at an appropriate frequency, thepulses can penetrate the scalp and induce a secondary ionic current inthe brain. Depending on the stimulation setting, single stimuli caneither excite or inhibit neuronal functions.

Accordingly, in certain limited instances, magnetic stimulation, e.g.,dynamic magnetic flux, can provide a non-invasive method for modulatingnerve function and has been proposed to be used for chronic painmanagement. However, aside from stimulating the brain, the use ofdynamic magnetic flux in transcutaneous stimulation for pain relief hasnot been established. This is the result of a number of issues: 1) thecurrent commercially-available magnetic stimulators are physically verybulky; 2) necessary coils usually require additional cooling units toprevent overheating; 3) the devices are too expensive to be accessibleto the general public; and 4) operating the device requires specialtraining and clinical expertise. These physical limitations, cost, andthe requirement of special training restrict the current scope of use ofthis non-invasive means of pain management outside of healthcarefacilities.

Accordingly, the need remains for a device that is affordable and easyto use that makes tMS an effective tool for management of chronic pain,readily available. The present disclosure is directed to devices,systems, and methods for addressing this unmet need.

SUMMARY OF THE DISCLOSURE

The present devices, systems, and methods accomplishes these goal byproviding for noninvasive pain therapy, including (but not necessarilylimited to) an automated positioning and tracking system that isprogrammed and/or configured to selectively position a magnetic coilproximate a target area so as to deliver chronic pain therapy to apredetermined nerve target location in a subject in need of therapy.

For instance, in one aspect, a transcutaneous magnetic stimulation (tMS)device including a magnetic coil is provided, such as where the tMSdevice is configured as a magnetic stimulator. In various embodiments,the tMS device may be coupled to a positioning element that isconfigured for assisting in the positioning and/or orientating of thetMS device so as to be proximate the site of treatment. This may beperformed manually or autonomously, such as through an associatedcontrolling device.

Accordingly, in another aspect, a system is provided, where the systemincludes a tMS device, configured for generating and direction atherapeutic magnetic field toward a treatment site, a positioningelement, such as a robotic arm, that is configured for orienting and/orpositioning the tMS device and/or magnetic coil proximate the treatment,and a control unit, such as a computing device, which is configured forcontrolling the operations of one or more of the tMS device, withrespect to the generation and/or application of the magnetic field, andthe positioning element, such as with respect to its movements inthree-dimensional space. In various embodiments, a distance determiningdevice and/or imaging component may also be included, where theplacement and positioning of the tMS device and/or magnetic coil may beaccomplished through the cooperative interaction of one or more of: thepositioning element, a stereoscopic camera, a micro laser distancescanner, and proprietary software operating on a computing system incommunication with the various components of the system. The devices andsystems of the present disclosure will greatly improve application ofnon-invasive chronic pain relief therapy.

Consequently, in a further aspect, one or methods is herein presented,such as for the therapeutic delivery of a magnetic flux to a site ofinjury or pain to a subject suffering therefrom. For instance, duringtherapy, the positioning element, which may include a robotic arm, maybe configured to function along with the other system components so asto precisely track and align the magnetic coil of the tMS device at thedesired area of treatment. In various instances, in so doing, the systemmay be configured to capture and/or build one or more three-dimensionalmeasurements and/or representations of the space in which the componentsof the system are operating within.

Accordingly, a 3-D measurement instrument and/or stereoscopic camera,and/or laser distance sensor may be configured to provide real timeposition feedback data of the patient/area of treatment, positioningelement, and tMS device with coil to the control module. Hence, usingthis data the position of the positioning element with respect to thetMS device and the target area and/or treatment site may be adjusted tomaintain/administer optimal therapy to the patient. The system may alsobe equipped with safety measures to allow system operation andapplication of therapy at minimal risk to patient and clinician.

In a particular embodiment, therefore, a system for deliveringtranscutaneous magnetic stimulation (tMS) to a treatment site on a bodyof a subject is provided. The system may include a tMS device, apositioning element, an imaging component, a distance scanner, areflective marking device, and a control module. For instance, thesystem may include a tMS device such as where the tMS device isconfigured for delivering a focused magnetic flux to the treatment sitewhen positioned proximate the body of the subject. Particularly, the tMSdevice may include a housing having an extended body, which includes aproximate portion having a proximate end, and a distal portion having adistal end. In certain instances, the extended body may define a cavityfor retaining one or more components of the tMS device. Likewise, thetMS device may include an insulated magnetic coil, such as disposedwithin the proximate portion of the extended body of the housing, wherethe magnetic coil is configured for generating and delivering a focusedmagnetic flux, e.g., at a determined pulse rate. The tMS device may alsoinclude a control module that is in communication with the magneticcoil, which control module is configured to control the focused magneticflux and the pulse rate to be delivered by the magnetic coil of the tMSdevice so as to deliver a magnetic flux to the treatment site of asubject to be treated.

The system may further include a positioning element, such as having aproximal portion including a proximal end, and a distal portionincluding a distal end, where the distal portion is coupled to themagnetic coil proximate the distal end. The positioning element may becomposed of a plurality of articulating arm members, where the pluralityof the arm members are coupled together by an automating element, e.g.,a motor, the automating element for assisting in the positioning of thetMS device proximate the treatment site.

An imaging component may also be included such as where the imagingcomponent includes one or more image capturing devices, such as acamera. In various embodiments, each image capturing device may beconfigured for capturing one or more images defining a three-dimensionalspace that is occupied by one or more of the subject, the tMS device,and the positioning element. A distance scanner may also be includedwhere the distance scanner is coupled to one or more of the housing ofthe tMS device and/or to the image capturing device, such as where thedistance scanner is configured for determining a distance between themagnetic coil and the treatment site on the body of the subject to betreated.

A reflective marking device may further be including such as forassisting with the positioning of the tMS device. For example, thereflective marking device may be positioned proximate the treatmentsite. In various instances, the reflective marking device may include aplurality of reflective elements that are configured for reflecting backa light emitted from the distance scanner in a manner sufficient forenabling the distance scanner to determine the distance between themagnetic coil and the treatment site.

Additionally, the system may include a control module that may becoupled to the proximal portion of the positioning element near theproximal end, such as where the control module is configured forcontrolling one or more of the tMS device, the positioning element, theimaging component, and the distance scanner. A further control unit,such as a stand alone desktop or laptop computer may also be provided,such as where the control unit serves as a master control unit for thesystem and is in communication with one or more of the tMS orpositioning element controllers.

Illustrative embodiments of the disclosure are described below. In theinterest of clarity, not all features of an actual implementation aredescribed in this specification. It will of course be appreciated thatin the development of any such actual embodiment, numerousimplementation-specific decisions must be made to achieve thedevelopers' specific goals, such as compliance with system-related andbusiness-related constraints, which will vary from one implementation toanother. Moreover, it will be appreciated that such a development effortmight be complex and time-consuming, but would nevertheless be a routineundertaking for those of ordinary skill in the art having the benefit ofthis disclosure.

The details of one or more variations of the subject matter describedherein are set forth in the accompanying drawings and the descriptionbelow. Other features and advantages of the subject matter describedherein will be apparent from the description and drawings, and from theclaims. While certain features of the currently disclosed subject matterare described for illustrative purposes in relation to an enterpriseresource software system or other business software solution orarchitecture, it should be readily understood that such features are notintended to be limiting. The claims that follow this disclosure areintended to define the scope of the protected subject matter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A provides a schematic representation of an embodiment of thesystem of the disclosure.

FIG. 1B provides an illustration of an exemplary positioning element andtranscutaneous magnetic stimulatory (tMS) device of the disclosure.

FIG. 2A provides an illustration of an exemplary tMS device having adistance measuring device associated therewith.

FIG. 2B provides an exemplary embodiment of the tMS device beingpositioned in proximity to a target area.

FIG. 3 provides an illustrative embodiment of the system determining theposition of a positioning element and tMS device within a 3-D space inaccordance with the teachings of the disclosure.

FIG. 4 provides an illustrative embodiment of a method for determiningthe distance between a magnetic coil of a tMS device from a target areaon a subject to be treated.

FIG. 5A provides a virtual grid-matrix for use in determining a targetarea for the application of a targeting protocol.

FIG. 5B provides a virtual grid-matrix for use in determining a targetsite for the application of a targeting protocol.

FIG. 5C provides a virtual grid-matrix for use in determining atreatment area for the application of a treatment site determination.

FIG. 5D provides a virtual grid matrix for use in determining atreatment site for the application of treatment.

FIG. 6A provides a representation of a graphical user interface (GUI)for use in configuring the system.

FIG. 6B provides a representation of a GUI for selecting a procedure tobe implemented by the system.

FIG. 6C provides a representation of a GUI displaying a trackingfunctionality.

FIG. 6D provides a GUI for displaying data pertaining to a status of thesystem.

FIG. 7A provides a representation of a GUI for displaying datapertaining to a misaligned tracking operation of the system.

FIG. 7B provides a representation of a GUI for displaying datapertaining to an aligned tracking operation of the system.

FIG. 8A provides a representation of a GUI displaying data a menu forselecting a process to be run by the system.

FIG. 8B provides a representation of a 3D matrix that may be used fordetermining the appropriate targeting for treatment.

FIG. 8C provides a virtual matrix that can be used in determining one ormore sites for treatment.

FIG. 8D provides a graphical representation of the virtual matrix ofFIG. 8C as presented at a GUI for use in targeting and applyingtreatment.

FIG. 8E provides a graphical representation for determining a depth offocus for the application of a magnetic field.

FIG. 8F provides a graphical representation indicating that thealignment protocol has been successful indicating that the device isappropriately aligned.

DESCRIPTION OF THE DIFFERENT EMBODIMENTS

Accordingly, the present devices and systems as well as the methods ofusing the same are provided for the purpose of reducing and/orameliorating the sensation of pain, specifically, chronic pain.Particularly, in one aspect, the devices, systems, and their methods ofuse disclosed herein are effective for reducing peripheral nerve pain,such as resulting from traumatic nerve injury and other types of nervedamage. For instance, generally, there are two types of pain that arethe result of injury. The first is acute, fast onset, mediated by A-δnerve fibers, while the second is a duller, slow pain, mediated by Cnerve fibers. For example, when a part of the body is injured, the firstpain felt is typically sharp, specific, and acute, while a few secondslater a more diffuse, dull pain is typically experienced.

These two different types of pain sensation are the result of theconductance of pain sensation by different nerve cells. Specifically,there are generally two types of pain fibers, A and C nociceptive nervefibers, which result in two types of pain sensation: fast and acute aswell as a slower more dispersed and duller sensation of pain.Nociceptive nerve fibers have free nerve endings (nociceptors) that formdense networks with multiple branches that connect the peripheraltissues and organs to the spinal cord. These nociceptors respond onlywhen a stimulus is strong enough to threaten the body's integrity, suchas when a stimulus or event is likely to cause an injury.

As indicated, these two distinct sensations of pain are distinguishableby the speed at which the different nerve fibers conduct theirsignaling. For instance, A and C fibers differ in the diameter andthickness of the myelin sheath that surrounds them, which affects thespeed at which these neurons conduct nerve impulses. Specifically, thegreater the diameter of the fiber and the thicker its myelin sheath, thefaster the nerve cells will conduct nerve impulses. More specifically, Afibers have a larger diameter and are myelinated, and therefore conductimpulses quickly, while C fibers have a smaller diameter, are notmyelinated, and conduct impulses more slowly. Accordingly, because oftheir differences in diameters and myelination, these different nervefibers have been adapted to serve different functions.

For example, A fibers can be divided into three sub-categories includingA-α fibers, which carry proprioception, or orientation, information,A-β, which carries information about touch, and A-δ, which carryinformation about pain, such as mechanical and/or thermal pain. C fibersalso conduct information about mechanical and chemical, e.g.,cold-sensation, pain, but with a slower conduction velocity.Accordingly, it is the difference between the speeds at which the twotypes of nociceptive nerve fibers (A-δ and C) conduct nerve impulsesthat distinguishes the two different manners in which pain isexperienced when injured, the first, A-δ, is mediated by a fast-painpathway that causes the immediate sharp, and acute pain, while C fibersform a slow-pain pathway that leads to the sensation of diffuse and dullpain. Likewise, A-α fibers regulate the sensation of pain as related toone's muscles. However, there is another, lesser-known pain pathway thatis mediated by an abridgement in homeostasis, which pain pathway isarbitrated by A-β. This pain pathway is exemplified by arbitratingneuropathic pain.

When in a homeostatic condition, e.g., in the absence of an acute paincausing event, everywhere in the body where pain is not felt, thisabsence of the sensation of pain is the result of a particular sensorynerve fiber, A-β, in that region that is constitutively active at abaseline level the functioning of which is to signal to the brain thathomeostasis is good and to be maintained. However, when that homeostaticcondition is perturbed, pain is perceived when there is trauma or damageto the nerve that results in a diminution of activity below A-β's basallevel. This decrease in activity signals to the brain that an injury tothe body, at site of onset, has occurred and as a result the braininterprets this drop in activity as a traumatic event and thereforesignals pain.

Particularly, the mechanism for this cause of action involves messagingfrom secondary, peripheral nerve fibers to the primary, first-ordernerve fibers in the dorsal root ganglia. More particularly, the dorsalroot ganglia constitute a cluster of neurons that form at the dorsalroot of the spinal nerve. These neurons include a collection of afferentaxons that function to relay sensory information, in this instance, adecrease in peripheral sensory activity, e.g., of A-β, from theperiphery to the central nervous system, e.g., brain, via the spinalcord. Specifically, when the peripheral A-β sensory touch fibers areactive, the dorsal root ganglia (DRG) filters both A-δ and C fiberactivity. However, when A-β activity diminishes, the filtering at theDRG switches off, and A-δ and C fiber signaling is then passed on to thecentral nervous system. Hence, it has been determined herein, that A-βsensory input play a suppressive role for repressing A-δ and C fiberactivity, and when that suppression is lifted, e.g., by a decreasedactivity of A-β, acute and/or chronic pain signaling is initiated.

Accordingly, in a normal condition, when a portion of the body suffersan injury, A-β activity is down regulated, and A-δ and/or C fiberactivity is increased signaling a pain response. When the body heals,homeostasis is re-established, A-β activity is increased, e.g.,gradually, and the pain is diminished. However, in some instances, suchas when the nerves are traumatically injured, even though the body mayheal, the nerves may not. Hence, in such an instance, e.g., of traumaticnerve injury, A-β activity remains down regulated, and because of this achronic sense of pain remains ongoing.

Unfortunately, until the Applicants' work in this field, there has beenlittle advancement towards the healing and/or amelioration ofneuropathic chronic pain caused by diminished A-β activity.Specifically, as indicated above, analgesics and/or opioids have beenproposed for the purposes of diminishing pain perception, however, forthe reasons stated above, analgesics are often not sufficient foralleviating pain, e.g., acute pain, and though opioids are ofteneffective for alleviating such pain, they are addictive and have beenthe cause of death for hundreds of thousands of American's world wide.Additionally, although useful for the amelioration of pain caused by A-δand C fiber activity, these medicaments are not particularly useful forreducing the chronic pain that results from a down regulation of A-βactivity.

However, because of the Applicant's realization of the A-β pain pathwayand its mechanism of action, as well as subsequent work performed inthis field, a device and a method for using the same for amelioratingpain, such as A and C fiber pain, especially A-β pain, is herebyproposed. More specifically, the inventor has determined that bystimulating the A-β nerve at the site of pain, A-β activity can beincreased, which in turn down regulates the activity of A-δ and C fiberactivity, thereby reducing the experience of pain. Such stimulation isdifficult to administer, however, because the A-β nerve fiber mediatestouch sensitivity. Particularly, because of this, any direct stimulationof the A-β nerve, e.g., such as through electro-stimulation, will resultin direct pain being caused due to hypersensitivity to touch and/ormaking contact with the site of pain, such as through electrodeinsertion. This difficulty has been overcome by a number of differentadvancements in the field made by the inventor hereof.

Particularly, it has been determined that the A-β nerve at the site ofpain can be stimulated in a non-invasive manner, such as byelectromagnetic stimulation. Likewise, it has further been determinedthat when such electromagnetic stimulation is administered at adetermined frequency, it can result in the activation of the A-β nerve,which, in turn, will result in the interruption of the pain response anda cessation of pain experience. More particularly, magnetic stimulationmay be administered at a current density so as to create a voltagedifferential at the axon of the A-β fiber thereby activating the variousvoltage gated channels therein, which in turn, results in the activationof A-β and the down regulation of by A-δ and C fiber activity.Accordingly, provided herein is a device for the application ofelectromagnetic stimulation of the nerve cells, specifically the nervecells associated with pain mediation, more specifically, A-β nervefibers.

It is to be noted that because it has been determined that A-β is a fastconducting nerve fiber, its signaling will reach the DRG prior to thatof A-δ and C fiber activity, thus, resulting in a cessation of theexperience of pain, so although one or more other nerve fibers may bestimulated, the rapid conductance of the A-β nerve fiber should assurethat its activation dominates the interaction in a manner so as to causea diminution in pain. Such stimulation may be generated in any suitablemanner so as to activate the A-β nerve fiber, e.g., above its basallevel, so as to increase the signaling that thereby down regulates thesensations of pain caused by the activation of A-δ and C fibers. Forinstance, such stimulation may be generated by a source of magneticstimulation or other stimulation that can activate the voltage gatedchannels in the nerve fiber and/or depolarize the nerve cell, such as inthe lease invasive manner.

However, although effective for lessening pain, the activation of A-βnerve fibers with magnetic stimulation is difficult to achieve.Specifically, in order to generate stimulation of the A-β nerve so as toproduce activation, the magnetic stimulation needs to be finely tuned,which means that it is very easy to go off of the treatment site.Consequently, to overcome these difficulties, the development and use ofthe electro-mechanical devices, systems, and their methods of usedescribed herein have been advanced for overcoming these difficulties.Specifically, in various embodiments, a mechanism for orientating a tMSdevice proximate an active region, e.g., a site of acute and/or chronicpain, such as within a determined range of effective administration ofelectromagnetic radiation, as well as the methods for delivering suchradiation are provided. More specifically, a mechanism for identifying atreatment site and orientating the administration of electromagneticradiation to a subject are provided, such as where the mechanismincludes a positioning element, such as a robotic arm, and theadministering element includes a tMS device.

Accordingly, in various embodiments, a robotic arm is provided as apositioning element for orienting an electromagnetic stimulation device,e.g., a tMS device. Specifically, a positioning element, such as arobotic arm, is useful for positioning a discrete magnetic field, suchas generated by a tMS device, proximate a treatment site in a mannerthat is sufficient to align a generated magnetic field in an orientationthat is capable of activating a nerve cell, such as an A-β nerve fiber,to thereby ameliorate the experience of pain at the treatment site.Accordingly, in various embodiments, a system for the positioning of astimulating, e.g., tMS, device is provided where the system functionsfor the purpose of orienting the tMS device proximate an identifiedtarget and/or treatment site. For instance, in various instances, apositioning element, e.g., a robotic arm, is provided so as to align adiscrete magnetic field with a fine nerve fiber in a manner such that agenerated magnetic field can activate the particular pain causing nervecell in a manner to raise its activity above a threshold level so as tothereby abate the experience of pain.

As indicated the stimulating device is typically a device for generatingand applying a force field so as to stimulate one or more nerve fibers,such as the A-β nerve fibers, so as to increase activity therein aboveits baseline condition. Particularly, the force field is a magneticfield, generated by a magnetic stimulatory device. Other fieldgenerating devices can be used, such as for delivering electromagneticradiation, light and/or electricity, and in some instances, though notideal, a physical stimulatory device may be employed, such as includingone or more electrodes, or needles, such as for increasing conduction,such as via an acupuncture style needle and/or electrode, such as inaddition to an appropriately configured EMG and feedback device.However, these modalities may cause a sensation of heating or burningand/or may cause pain via direct contact with the nerve, which is notideal, and these modalities are further complicated by the highimpedance of the skin. More particularly, with respect to electricstimulation of the A-β nerve fiber, another difficulty is that currentflows through the path of least resistance, and thus, applying currentand directing it to the identified nerve fiber is difficult to do andmaintain, especially, when the subject is hyper sensitive to touch as isthe A-β nerve fiber. Likewise, the introduction of new electrons willchange the physics and chemistry of the tissue and/or affects theconcentration gradient.

Application of a therapeutic treatment in these regards is difficult todo, in part, because it is challenging to identify a specific nervefiber, e.g., an A-β nerve fiber, amidst all the other cell tissueswithin a given region of the body, and is further complicated by thedifficulty of determining the necessary characteristics of the magneticfield that are sufficient to generate nerve activation within theappropriate parameters. Additional difficulties surround the targetingof the generated magnetic field with the appropriate characteristics insuch a manner that the generated field actually arrives at theidentified nerve tissue and in the appropriate condition to provoke thedesired activation. Further complications include making this targetingand administration consistent over treatment regimes and across amultiplicity of treatment days. More specifically, because the variousdifferent nerve tissues are disperse, and the distribution of theirnociceptors form dense networks with multiple branches, targeting aparticular nerve cell, e.g., an A-β nerve fiber, for receipt of the finetuned magnetic stimulation is problematic.

A systematic method, therefore, for targeting and treating a site ofchronic pain is hereby provided. In various embodiments, this method mayinclude one or more of the following steps: Defining a target area of asubject's body in need of treatment; Positioning a magnetic stimulationdevice proximate the defined target and/or treatment area; Determiningone or more characteristics of a magnetic wave to be delivered to thetarget area; Administering the determined magnetic stimulation to thetreatment site, e.g., in a manner to provoke bi-lateral stimulation in anerve cell, e.g., an A-β nerve fiber; Eliciting feed-back from thesubject so as to evaluate the effectiveness of the targeting; and thenoptimizing for depolarizations of the targeted sensory nerve fiber, suchas by varying the amplitude of the waveform.

There are several ways by which these objectives may be achieved. Forinstance, a grid-like structure may be applied to the treatment regionwhereby the treatment region can be broken down into sub-regions andthrough an iterative process of application of magnetic stimulation anarrowly defined active site can be identified. For example, a grid ofrows and columns forming boxes can be applied to the treatment region.In particular embodiments the grid can be formed from 3 to 6 to 9 to 12to 16 boxes that together form a larger box that defines the boundariesof the target region. The boxes can vary in size, such as where each boxmay be from about 3×3 mm to about 9×9 mm to about 12×12 mm in area,depending on the target are and/or treatment site, e.g., whether it'ssmaller than a finger or larger than hand, etc. Regardless of size,stimulation can be delivered iteratively to the various sub-regions ofthe target region until all areas proximate the treatment site have beensuitably identified.

Specifically, when a magnetic pulse is delivered to the appropriate painsignaling nerve fiber, in the correct orientation, so as to stimulateactivity in the nerve cell, a concomitant dulling of the pain will beexperienced by the subject, and the box defining that targeted site canthen be identified as part of the treatment area. This process can berepeated until an adequate number of areas have been identified so as todefine the treatment site such that by applying one or more magneticpulses to the treatment site results in the diminution and/or totalabeyance of pain sensation. For instance, in various embodiments, thegrid may be laid out like a telephone key pad with numbers from 1 to 9,stimulation is provided to each number, e.g., sequentially, and for eachnumber the subject can self-report an evaluation on the paindiminishment, such as using a scale from 1 to 10, and in this mannereach box particularly defining the precise bounds of the treatment sitemay be defined.

Particularly, by aligning the active boxes, the topographicaldistribution of the nerve may be defined such as by horizontally,vertically, or diagonally aligning the active boxes, e.g., where threesequential numbers demarcate a horizontal distribution pattern, anynumber separated by three demarcate a vertical distribution pattern, anda sequence of odd numbers demarcates a diagonal distribution pattern. Ofcourse, other patterns can also be identified based on thecharacteristics of the nerve distribution.

Accordingly, in a manner such as this the nerve to be treated may beclearly identified, localized, and treated, as discussed herein,resulting in a decrease of pain sensation. In certain embodiments, oncethe treatment site has been localized, it may further be defined intosmaller units, so as to further refine the locus of pain origination.Additionally, depth may be accounted for by varying the amplitude and/ordistance of the stimulation device from the site of treatment.

Further, in various instances, the dimensionality of the treatment sitemay be catalogued in such a manner that treatment can be delivered tothe same position in the same orientation so as to make theadministration of the magnetic field uniform. In this manner, the use ofan automated delivery vehicle, such as a robotic arm, for thepositioning of the source of magnetic energy application, e.g., the tMSdevice, is especially useful because it allows for a degree ofcertainty, e.g., sub-millimeter accuracy, in the positioning andorientation of the application device with a rapidity above that whichcan be achieved without such use.

For instance, it is extremely difficult, if not impossible, to positionthe magnetic stimulation device in the same position for any two giventreatment sessions, if it is positioned by human hand. Particularly,when positioning the stimulation device by hand, fine motor movementsare required beyond that which is humanly feasible, and thus, bothunder- and overcompensation often results. More particularly, it ispractically impossible to achieve a repeat in locality of applicationbecause human motor skill development does not provide for millimeterand sub-millimeter accuracy in positioning, with respect torepeatability and accuracy.

Another advantage of an electronic positioning element, such as arobotic arm, is motion compensation. Specifically, motion compensationis difficult to achieve and maintain in a non-animated format.Particularly, it is difficult to effectuate localization in areproducible manner. Often performing this task manually is timeconsuming and can result in causing pain to the subject to whom thetreatments are being administered. For instance, manual localization canroughly be achieved in from about 15 to about 20 or 30 minutes, and isnot readily reproducible across treatments, while using an automatedsystem, as disclosed herein, this time can be reduced to under 5minuets, such as under 3 minutes, particularly under 1 minute and 30seconds, such as under 60 or 45 or 30 seconds or less, without causingsubstantial pain to the subject. This localization task is made moredifficult because the nerve fiber to be treated is a very fine nerve,and during attempted administration, the subject has a tendency to move,if ever so slightly, which can then go off the treatment site.Particularly, where the nerve to be treated is sub-millimeters inlength, a small adjustment of the subject can result in a wide miss ofthe treatment site, with little fine-movement of manual manipulation ofthe application instrument.

The present system, however, is configured for performing fine-tunedtarget locking and movement compensation, which allows for increasedfocusing on the optimal target site. More particularly, results haveshown that even though manual targeting is useful, such as with a 30%efficacy, when using the present system efficacy can be increased byabout 5% or 6% to about 10% or about 20%, and in some instances, anincrease of about 30% to about 40% or about 50% or more, which can beaccretive over time with additional sequential treatments. Hence, evenat the low end, after three treatments, by the third treatment thesubject can experience about a 60% to about a 70% or 75% or even up toabout 80% or 85% reduction in pain, and in some instances, about 90% or95% or more.

Thus, the use of the present positioning system not only solves for theproblem of position error, such as by targeted application, but alsoresult in an increase in effectiveness and/or efficacy in treatmentsoverall. For instance, it has been observed that after a plurality oftreatments, such as 2, 3, 5, or 6 or more, the length of time betweentreatments may be extended for longer and longer periods of time, suchas due to increased periods of the absence of pain. In one example,after 3 treatments in the first week, a whole month of pain relief maybe observed. Hence, after one-month, the subject may only need treatmentonce a month for an entire month of pain relief.

Additionally, in various embodiments, a visioning module such asincluding an imaging device, such as a 3-D scanner, can be used to scanand image the treatment site so as to generate a three-dimensionalrepresentation of the treatment site, which further increases bothtargeting and effectiveness and further increases repeatability. Forinstance, the imaging device may include a lighting element and animaging capturing device. Specifically, the lighting element may becapable of generating ultraviolet, visible, or infra-red electromagneticradiation. For instance, the lighting element may include a series oflighting elements that are positioned proximate one or more of thelenses of the image capturing component. Particularly, a plurality oflighting elements are configured so as to circumscribe a circumferenceof the image capturing component itself or one or more lenses thereof.For example, a collection of lighting elements may be positioned aroundeach lens of a camera element, such as a stereoscopic camera element. Inparticular instances, the lighting elements may include or otherwise maybe replaced by one or more sensors, such as a distance measuring sensor.In certain instances, the lighting element is a semiconductingelectrode, such as a concentrated light emitting diode, LED, and theimage capturing device may be configured for capturing infra-red imagesof the tissue and/or cellular structures of the target site and nerve(s)to be treated. In a particular instance, the image-capturing device maybe a camera, such as a complementary metal-oxide semiconductor, CMOS,camera, that is capable of generating a three-dimensional image of thetreatment nerve(s) at the treatment site.

Hence, once the treatment sight has been scanned a 3-D topographical mapof the site may be generated, then the appropriate nerve tissue can beidentified, and the dimensionality of the nerve to be treated, withrespect to its surrounding tissues and structures and/or distance ofdevice from the target and/or treatment sites, can be identified, andthe treatment site and/or application distance can be clearly demarcatedand bounded. With such mapping the automated positioning element andmagnetic flux delivery vehicle, e.g., tMS device, can be preciselytargeted, such as with respect to depth, angle, orientation, and thelike, so as to deliver treatment to the nerve cell with pinpointaccuracy and fine-tuned repeatability over a number of differenttreatment days.

For instance, the automated positioning element and/or tMS device mayinclude an orientation sensor that is capable of determining anorientation of a component of the system, such as the tMS device, and/ormay include a pressure sensor, such as for sensing forces in aplurality, e.g., all, directions, such as a force torque sensor. Thesystem may also include a time of flight sensor, such as in conjunctionwith, or otherwise coupled to, the visioning system. In variousinstances, the positioning of the positioning element may be controlledmanually, e.g., by an operator, or may be controlled automatically bythe system. Likewise, the system may be configured for retracting thepositioning element if there is something that gets in the way of itsmovements, its imaging, and or the application of the tMS device, or ifit senses the presence of an aberrant or harmful condition.

Configuring the system to autonomously control the positioning of thetreatment apparatus cuts down on time and cost and unpredictabilityinherent to having a technician controlling the operations thereof, andcan increase safety. This is important because of the nature of the A-βnerve fibers that are very sensitive to touch such that even slight,gentle contact with the target site can cause an intense experience ofpain. In various embodiments, the subject themselves can autopilot thepositioning elements of the system, so as to self-administer thetreatment. In various instances, the system including the visioning andapplication modules can be configured to target, manipulate, and adjustthe system components, such as with respect to position, distance, andorientation of the device vis a vis the target site, and can constantlybe checking and double checking one or more of these conditions, such a100 or 200 or 400 or 500 or 1000 or more times a second, such as via thevision and orientation sensor systems, for instance, time of flight

Accordingly, in various embodiments, presented herein is a therapeuticsystem and method for treating chronic pain, which system andmethodology boasts a variety of unique components and features thatindividually and in combination demarcate an exceptional advancement inthe art. For instance, as can be seen with respect to FIG. 1, in variousembodiments, the pain treatment system may include one or more of thefollowing components: a magnetic induction device 10, e.g., including amagnetic coil 15, an image capturing device 30, a positioning element20, one or more sensors 60, a system controller 70, a remote server 80,and one or more control switches.

Particularly, the pain treatment system 1 may include a magneticinduction arrangement. The magnetic induction arrangement 5 may includea control unit 70 and a source for generating a magnetic field 10. Anysource for generating a focused magnetic field may be used. In variousinstances, the source may include a magnetic coil 15, such as a coilhaving a plurality of coil interfaces, e.g., 15 a and 15 b. Forinstance, the magnetic coil 15 may be configured as a figure eight or abutterfly coil. In various instances, the magnetic induction device 15may be configured as a stimulatory device that is configured forgenerating a focused magnetic field, which in turn is capable ofgenerating a concomitant electrical current, such as within a nervetissue. In a particular instance, the magnetic induction arrangement isa transcutaneous magnetic stimulation (tMS) device 15. Likewise, thecontrol unit 70 may be any mechanism configured for generating andcontrolling the energy sufficient to allow the magnetic coil to generatethe magnetic field.

Further, in various embodiments, the system 1 may include a positioningelement 20 that is configured for positioning and/or orienting amagnetic stimulatory device 10 proximate a treatment site of a subject,such as a subject experiencing pain and/or in need of treatment. Thepositioning element 20 may be any device that is capable of moving,positioning, and orienting a stimulatory element, e.g., tMS device 10,in proximity of a nerve, such as a nerve radiating pain, so as togenerate a magnetic field, which magnetic field is capable of creatingan electric pulse in the targeted nerve cell that is sufficient todepolarize the nerve, thereby activating the nerve, and causing acessation of pain.

For instance, in various instances, the positioning element 20 may be anarticulating arm device, such as an arm that is composed of severalsegments 20 a, 20 b that may be coupled together via one or moremoveable joints, which joints may include one or more motors 21 a, 21 b,21 c, such as a moveable joint and/or motor(s) that allows the arm tomove or otherwise articulate along one or more planes, such as along oneor more of an X, Y, or Z plane. In particular instances, the one or moremotors may be configured for facilitating the movements of one or morearm segments along one or more X, Y, and Z planes, and may furtherfacilitate movement along an X, Y, or Z axis. Accordingly, in variousembodiments, the positioning element may be moved manually and/orautonomously.

Accordingly, in various instances, the positioning element 20 mayinclude a control unit, such as a control unit that is in communicationwith the one or more joint motors 21 and is configured for articulatingthe positioning element 20 and/or one or more portions of the element 20a, 20 b. Specifically, where the positioning element is an articulatingarm 20 composed of a plurality of segments 20 a, 20 b coupled togethervia one or more motors 21, the control unit may be configured to sendcommands to the motors so as to control their activation and therebycontrol the motions of the segments of the arms, such as horizontalmovement along an X plane, or vertical movement along a Y plane, ordiagonal movement along a Z, and/or rotational movement around an X, Y,and/or Z axis. In various instances, one or more motors of a pluralityof arm segments of the positioning element may be configured fordirecting orthogonal movement of the positioning element.

In various embodiments, the positioning element 20, e.g., thearticulating arm, may be configured to be manually articulated, and/ortherefore may be manually positioned. However, in other embodiments, thepositioning element 20 may be configured for being positionedautomatically or semi-automatically. For example, in particularinstances, the movements of the articulating arm 20, or otherpositioning element, may be controlled by a central controller 70, suchas a controller 70 that is configured for controlling the various motors21 of the positioning element 20 so as to direct its movements inthree-dimensional space. Accordingly, the positioning element may be arobotic arm 20 that is not only configured for being moved in a planarmanner in 3-D space, but is also capable of rotating about each centralaxis, such as automatically or otherwise autonomously.

Additionally, the system 1 may include an imaging unit having an imagecapturing component 30, which component may have a camera for capturingimages, for instance, for taking pictures or video. For example, animaging unit may be included as part of the system, such as where theimaging unit is configured for imaging one or more spaces, such as theinterior or exterior space in which the subject is occupying and/or theexterior space in which an included positioning element is moving orcapable of moving.

Particularly, the system 1 may include an imaging unit 30 such as fordetermining where and in what orientation the positioning element 20 isin space, where and in what orientation the magnetic induction element10 is in, and/or where and in what orientation the subject, or a part oftheir body is in, such as a part of their body to be treated. In someinstances, the imaging component may be configured for determining therelative positions of the various elements of the system 1.Specifically, the imaging unit 30 may be configured for determiningwhere the magnetic induction element 10 is relative to a targetedtreatment site on the body part of the subject being treated.

For instance, in various embodiments, the imaging unit 30 may include aplurality of cameras 30 a, 30 b, which cameras are configured fordefining a three-dimensional space in which the positioning element ismoving, and/or for defining a three-dimensional space occupied by thepatient, and for moving and orienting the positioning element 20relative to the body part being treated so that the magnetic inductiondevice 10 may be brought into proximity and orientation of the body soas to efficiently deliver a magnetic field to the body part.Particularly, in certain embodiments, the imaging unit 30 may beconfigured as a stereoscopic camera that is adapted for capturingimages, such as 3-D images of a given space in which the positioningelement 20 operates. In various embodiments, the imaging component, suchas the camera 30, e.g., the stereoscopic camera, may include one or morelenses 30 a, 30 b, such as a plurality of lenses having a determinedfocal length.

Additionally, in particular embodiments, the imaging unit 30 may includea light source 40, such as for illuminating an area, for taking ameasurement, determining a distance, and the like. The light source 40may be a plurality of light sources such as a collection of lightemitting diodes (LEDs). The LED lights 40 may be positioned on theimaging unit, such as on or around the imaging component and/or thecamera lenses. For instance, one or more of the light sources may bepositioned proximate a circumference of at least one of the cameraand/or the camera lenses, such as including 2, 3, 4, 5, 6, or morelighting sources that may be positioned proximate a circumference of oneor more lenses. In a particular embodiment, the lighting source mayinclude LED lights may be configured for emitting a light wave in theinfrared spectrum, such as for use in determining movement in a defined3-dimensional space and/or for determining one or more distances ororientations therein, and/or for determining a speed, acceleration, ordirection of motion.

Further still, another component that may be included as part of thesystem is one or more sensor modules 60 such as including one or moresensors 60 a, 60 b. For instance, a sensor module 60 may be includedsuch as where the sensor module includes a distance sensor 60, such as asensor that is configured for determining the distance between one ormore of the positioning element 20, the magnetic induction unit 10, andthe target site on the subject to be treated. Specifically, a distancesensor 60 of the system may be any element that is configured to detector otherwise determine the distance between two objects. Thisdetermination may be made by a calculation of distance over time, suchas by calculating the time it takes for a sound or light wave to travelto and/or back between the sensor and an object. For example, thedistance sensor 60 may be a unit that is configured for emitting a soundor light wave, such as a laser, which wave travels to and/or back froman object, such as a reflective object at a known velocity, and from thetime it takes to make this journey the distance to the object may bedetermined. Accordingly, in a particular embodiment, the distance sensor60 may include a laser, such as a micro laser distance scanner.

A motion or pressure sensor may also be included. For instance, a sensorconfigured for determining contact or near contact between the subjectbeing treated and the treatment device, such as the positioning elementand/or the magnetic induction element, may be included and configuredsuch that when a contact occurs or is expected to occur, the treatmentdevice may be withdrawn so as to minimize or entirely avoid suchcontact. Particularly, the active site of the subject being treated maybe very reactive to touch. So being the treatment device may include oneor more sensors that are configured to determine the movements of thesubject, to track the movements, to characterize the movements, such aswith respect to speed, direction, orientation, and the like, and inresponse thereto one or more of the motors of the device can beactivated so as to effectuate the tracking of the device to thesubject's movements and/or withdrawal of the device away from thesubject if contact is made or expected to be made. In a particularembodiment, the sensor may be a torque-force sensor that is configuredfor withdrawing the positioning element and/or magnetic induction deviceif contact is experienced or suspected to occur.

Additionally, the system 1 may include one or more computer 70 or server80 systems. Particularly, the various components of the system 1 may becommunicably coupled one to another and to a computer 70 and/or serverof the system 80, such as in a wired or wireless configuration, such asvia a network 90, such as via a private or public network, e.g., theInternet. For instance, in various embodiments, the system 1 may includea computer 70 and/or a server 80, such as a local computing resource,such as for controlling the local functioning of the system components,and a remote cloud-based server, such as a server in connection with aplurality of local computing resources, where one or more of the localor remote computing resources may be coupled to a memory and/or externaldatabase.

Specifically, in particular embodiments, a cloud-based server 80 may beincluded. For instance, a cloud-based server system 80 may be providedsuch as for storing and/or processing data, such as data pertaining toone or more subjects. The server system 80 may be configured forreceiving data directly from one or more of the positioning element 20and/or the magnetic induction device 10, or the server system 80 mayreceive data indirectly from a local computing resource 70 that isitself coupled to the positioning element 20 and/or the magneticinduction device 10 and/or the imaging component 40, all of which may bein communication one with the other. Specifically, in one embodiment,the local computing resource 70 may be a desktop computer, laptopcomputer, tablet computer, smart phone computing device, and the like.Likewise, the remote server system 80 may include a LINUX® server havinga plurality, e.g., 6, 12, 18, 24 or more CPUs or GPUs, which CPUs andGPUs may be coupled to a suitably configurable FPGA that is adapted forperforming one or more of the analyses and/or processing operationsdisclosed herein.

In certain instances, the system 1 may include a remote server 80 thatincludes a plurality of different computing instances, such as a CPU,GPU, and/or an FPGA, ASIC, and the like, and as such, any of theseinstances can be configured for implementing one or more methods of thesystem. Where an FPGA is provided, the FPGA(s) may be adapted for beingreconfigured, such as partially reconfigured, between one or more of thevarious steps of implementing one or more of the system parameters. Invarious embodiments, the local computing resource 70 and/or the remoteserver 80 may be configured for assisting in the running the variouscomponents of the system 1 and/or for collecting data pertaining to theoperations of the components and/or data pertaining to the treatment ofone or more subjects.

One or more of the local computing resource 70 and the server system 80may be configured for running one or more analytics on the collectedand/or stored data. Hence, using a local computing resource or another,remote client computer the cloud accessible server system and/or astorage device thereof may be accessed, such as for the storage and/oranalysis of data. For example, a remote user may access the system so asto input patient data, e.g., treatment data, into the system, such asfor storage and/or the processing thereof. Particularly, a remote userof the system, e.g., using local computing resource, may access theserver system so as to upload patient data, e.g., such as one or moretreatment parameters or results thereof of one or more individuals. Invarious embodiments, the system may include a user interface, e.g.,accessing a suitably configured application programming interface, API,which will allow a user to access the server so as to upload data to beprocessed, control the parameters of the processing, direct systemconfigurations, and/or download output, e.g., results data, from thesystem. In particular embodiments, the local or remote computingresource may include a workflow management controller that is configuredto control one or more aspects of the system, such as locally and/orglobally, e.g., system wide.

In various instances, the system and/or a component thereof may includea communications module, which communication module may include one ormore communications devices such as for providing a communicable linkbetween two or more components of the system. For instance, acommunications device may include a transmitter and/or a receiver, suchas including one or more of a radio frequency (RF) transmitter, acellular transmitter, a WIFI transmitter, and a Bluetooth or Low EnergyBluetooth transmitter that is adapted in a manner so as to allow asuitably configured component of the system to be accessible wirelesslyand/or remotely. In some instances, a typical receiver may include asatellite based geolocation system or other mechanism for determiningthe position of an object in three-dimensional space. For instance, thegeolocation system may include one or more technologies such as a GlobalNavigation Satellite System (GNSS). Exemplary GNSS systems that enableaccurate geolocation can include GPS in the United States, Globalnayanavigatsionnaya sputnikovaya sistema (GLONASS) in Russia, Galileo in theEuropean Union, and/or BeiDou System (BDS) in China.

In various embodiments, the system may include one or more safetymonitors and/or shutoff mechanisms such as for determining if and when asafety risk may arise, and upon such a condition may function towithdraw the system components from the treatment site, power down,and/or shutoff the system. In particular embodiments, the safetymechanism may be configured as a safety command device, such as anelectric or mechanical switch mechanism for retracting the magneticinduction device and/or positioning element and/or for shutting down oneor more of the system components.

Accordingly, in various embodiments, a system is provided for manuallyand/or automatically providing one or more therapeutic and/orprophylactic treatments to a subject at risk of suffering from pain,such as acute and/or chronic pain. As indicated above, and as seen inFIG. 1B the system 1 may include a transcutaneous magnetic stimulation(tMS) device 10. The tMS device may be configured for directing a lowand/or medium, and/or high frequency magnetic field toward a determinedtreatment area. For instance, in various embodiments, the tMS deviceoperates within a frequency range from approximately 0.2 Hz to about 5Hz. Specifically, the frequency range may be divided into a lowfrequency stimulation range from approximately 0.2 Hz-1 Hz and a highfrequency range from approximately 1 Hz to 5 Hz. Particularly, the tMSdevice 10 may provide a pulse having a varying magnetic pulse fieldstrength and/or varying voltage. For example, the magnetic pulse fieldstrength has a continuous stimulation capacity of up to about 1 to about3 to about 5 or more Tesla. In various instances, the waveform producedmay be a single or a biphasic waveform. In particular instances, thewaveform may be biphasic waveform that is effective with regard to thethreshold of excitation and response amplitude of the underlying nervereceiving the magnetic pulse.

In particular embodiments, the tMS device may include a housing 11 thatis configured for allowing the tMS device to be handheld, and in otherinstances the tMS device housing is configured for being coupled to apositioning element 20, such as for being coupled to a robotic arm. Invarious instances, the housing may be of any suitable size and/orconfiguration, but in particular instances, the tMS housing measuresapproximately 3 to 5 to about 10 inches in length, approximately 1 to2.5 to about 5 or more inches wide, and approximately 0.5 to 1.5 toabout 3 inches deep. Where a handle portion of the device is provided,the handle portion of the tMS device may extend approximately 3 to about5 or about 7.5 to about 10 inches from the coil portion, and may beadapted to allow for the tMS device to be handheld or mounted duringuse.

The tMS stimulator 10 may be configured for generating a magnetic fluxor field that in turn produces small electrical currents around aneuroma or nerve entrapment, and can be applied without anesthetics. Incertain instances, the tMS device includes a magnetic coil 15 that maybe an insulated, whereby the magnetic coil can be held over a targetand/or treatment area either with or without contacting the affectedarea. In various instances, the tMS device is positioned so as to nottouch the target or treatment area. This method of pain neuromodulationprovides a major advantage in treating patients with increasedsensitivity to non-noxious stimuli (allodynia), for instance, as thetreatment does not require direct device-patient contact or directtissue penetration. Accordingly, the dynamic magnetic flux produced bythe tMS device may be configured to induce neuronal stimulation in amore focused manner than can be generated by other direct currentstimulation modalities, such as a transcutaneous electrical nervesstimulator (TENS).

Hence, the tMS device 10 is configured for delivering a directed amagnetic flux to a target and/or treatment area. Specifically, when acurrent is passed around the coil 15, a dynamic magnetic flux will passthrough the skin and into a selected depth, such as a first fewcentimeters depth of the skin, which may be delivered withoutattenuation. In various instances, the tMS device may be configured toeffectuate a treatment whereby the current required is decreased fromapproximately 1200V to about 700V. Particularly, the tMS device isconfigured to produce a focused dynamic magnetic flux from the center ofthe coil 15 to the target and/or treatment site which can be marked,e.g., in any suitable manner, such as with an extended opticalcross-hair in order to target a specific area on the body. In oneembodiment, the coil 15 may have a magnetic core of permalloy, Mu-metal,or other ferromagnetic compound, which may be assembled in the center ofthe coil to further increase the strength of the magnetic flux. In oneembodiment, the magnetic core is shaped into a figure-of-eight coil 15that includes a left coil 15 a and right coil 15 b.

More particularly, the figure-of-eight coil 15 may rotate internally upto approximately 30 degrees in order to adjust a focal point of thetreatment by redirecting the magnetic field. Specifically, in variousinstances, the focal point may be focused to within approximately 3-5millimeters in the rotated configuration. For instance, the magneticcoil 15 may be configured to rotate the configuration of thefigure-of-eight coil, which may be rotated via a central gear mechanismattached to a curved mounting piece. More specifically, the curvedmounting pieces may be metal pieces that are attached to the coils viascrews or any other practical attachment mechanism. The gear mechanismmay be driven by a small motor attached with a central gear, such aswhere one or more of the coils may be connected with the gear mechanismthrough a single secondary gear. The opposing coil, therefore, may beconnected with the gear mechanism through two or more secondary gears soas to effectuate an opposite direction of rotation of the coils so thatthey both rotate inward to focus on a single target point. This rotatedconfiguration occurs through the motor actuating the gears to rotate thecoil via the mounting pieces.

In various embodiments, the system 1, and specifically, the tMS device10 may include a light source, such as an LED. The light source may bepositioned on an application side of the coil portion that faces thebody, so as to guide a center of magnetic flux generated by the coil toa target and/or treatment area and site. The tMS device, and/or anassociated positioning element 20, may also include a motion sensor,such as an accelerometer and/or gyroscope, which may be configured todetect motion, direction, magnitude, and/or velocity of the motion ofthe tMS device and/or positioning element. In various instances, thesensor may be able to detect motion and acceleration as well as to senseorientation, vibration, shock, pressure, and/or contact, such as for thepurpose of withdrawing and/or turning off the device during deviationsfrom treatment locale.

For instance, a magnetometer may also be included to measure thestrength and direction of one or more magnetic fields generated by thestimulation coils 15 to optimize accuracy and intensity of treatments.Further, a proximity sensor may be included to detect and confirm thatthe target region and/or treatment area is within the appropriate rangeof the tMS stimulator 10 to precisely deliver treatment to achieve thegreatest results. Likewise, the tMS device 10 may be designed with athermode or other control switch so as to automatically shut off thestimulation device in the event of overheating from both internal andexternal factors. Particularly, in a particular embodiment, the tMSdevice 10 may be coupled to a controller, where by for efficiency, thecontroller software of the controller may utilize a negative-feedbackmethod so as to detect unusual heating patterns to prevent damage to thedevice, or injury to the operator or patient, by warning them andturning off the device.

The circuit design for operating the tMS device has been configured soas to optimize efficiency. For instance, the circuitry may be adapted tocontinuously monitor and adjust power outputs to ensure efficacy of thetreatment and safety of the user. Crucial circuit components may betested in every power cycle, before and after each treatmentadministration with the primary hardware supervisory circuits andsecondary software monitoring systems in communication with the controlcomponents of the system, including control unit 70. Particularly, thecircuitry may be configured to boot, e.g., in stages, and if a failureis detected, a safety interrupt may be implemented so as to discontinuethe booting process, shutdown device operation, and ask for servicing.The circuitry inside the controller, if included in the tMS device, mayalso include parallel high voltage chargers, such as where each iscapable of up to 1600 or more watt power output, energizing capacitorbanks, with up to 2200 or more uF energy storage capacity, anddischarging hardware to decrease loss of performance and increasereliability. In various instances, the capacitor bank inside controlmodule may range in voltages from −2000 to +4500 volts DC or more inorder to conserve energy and optimize performance. The repetitivecontrollable on-state current within the controller and stimulation coil15 may reach up to 4000 volts DC or more. In one embodiment, multiplehigh power converting thyrisitors may be stacked to achieve theperformance requirements of this pulsed power application. Heat frominductance may be managed internally with small, electrically powered,forced-air cooling systems, such as utilizing continuous duty DC blowerfans, e.g., operating at up to 5200 RPM or more. In one embodiment, thesystem 1, positioning element 20, and/or tMS device 10 can be password-or biometrically-protected to ensure access only by approved users ofthe device.

As set forth in FIG. 1, the system may include a control module 70 thatis configured for controlling the operations of one or more of thecomponents of the system 1. For instance, the control module 70 mayinclude a computing system, such as a desktop or laptop computer, etc.that is in wired or wireless communication, e.g., via a wireless networkinterface, with one or more of the tMS device 10, the positioningelement 20, the imaging component 30, one or more sensors of the system,a lighting element 40, and/or a cloud-based server system. The controlmodule 70 may further be in communication with a controller of thepositioning element 20 and/or one or more of the motors thereof. Inparticular embodiments, the control module 70 is configured withhardware and software to precisely control the tMS stimulator 10 and/orpositioning element 20 so as to provide instructions and/or receivefeedback relating to the treatment, such as in real-time andpost-treatment.

The control module may be controlled by any suitable mechanism such asvia one or more control instruments, e.g., a button, toggle, switch, andthe like, or may have a touchscreen interface, such as a touch-sensitivecapacitive touch-screen display, through which control instruments thesettings of the control module may be adjusted. In various instances,the touchscreen display may present tMS device information or connectionstatus indications pertaining to connections with the system componentsor another network device. For instance, the control module may displaythe controls for modulating the pulse width, amplitude and frequency ofthe treatment, and may be configured for displaying real-time signaldata on the applied fields, all of which may be controlled via a controlinstrument of the control module, or may be controlled such as via adownloadable client application that runs on a mobile computing device,such as a smart phone. Specifically, the control module may beconfigured for controlling the positioning of the positioning element 20components, the orientation of the tMS device 10, and/or an output ofthe tMS device. For example, in a particular embodiment, a suitableoutput of the tMS device may be 3 T at 1 Hz, with 20 KTesla/secinstantaneous flux. However, in other embodiments, the output may be areduced output such as at approximately 1.5 Tesla and 3 pulses persecond (PPS). Further, in particular instances, the system 1 may beconfigured for in-home use, such as where a suitable output may beapproximately 3 Tesla and 5 PPS, where as in a clinical setting, theclinical tMS device may be capable of outputting approximately 4 Teslaand 50 PPS.

Accordingly, in various instances, the system 1 may include one or morecomponents that may be controlled by one or more internal controllers,and/or the system may include a control module 70 that is separatedevice from the treatment delivery components. In either instance, acontrol mechanism of the system may be configured for performing one ormore of the following: directing delivery of a specified pulsecharacteristic, e.g., rate; determining a particular magnetic fieldcharacteristic, e.g., having a specified strength; determining asuitable target and/or treatment area; controlling the positioning ofthe positioning element and/or tMS device; and directing the tMS deviceto deliver one or more pulses at specified rate and strength. Asindicated, the control module 70 may be in a wired or wirelessconfiguration.

For example, the control module 70 may include a wirelesstransmitter/receiver and corresponding software to provide a wirelessconnection with another component of the system. Particularly, thecontrol module 70 may be in communication with one or more sensors ofthe system so as track the movements and/or functionings of thecomponents of the system. In this manner, the controllers of the systemmay act in concert to manage the application of one or more treatmentsto a subject, e.g., a patient, in need thereof.

Likewise, as indicated, one or more of the controllers of the system maybe configured for receiving command instructions, e.g., via a remoteclient application running on a computing device of a remote operator,such as for remotely programming treatment parameters, troubleshootingassistance, updating software, and to ensure compliance. Accordingly, inan exemplary embodiment, the controllers of the system may be equippedwith a communications device, such as BLUETOOTH®, e.g., low energyBLUETOOTH® 4.0 technology, which provides connection to one or moreother controllers, a cloud based server 80, and/or a remote computingmobile device, e.g., a smart phone or tablet computer, for tracking andmanaging treatment, patient feedback, and results, so as to optimizetherapeutic parameters and maximize analgesic efficacy. In variousinstances, a component of the system, such as a control module 70 may beconfigured so as to be powered by AC or DC electricity or a rechargeablebattery. In one embodiment, the control module may be equipped withrechargeable batteries (Lithium-ion & Sodium-ion) or graphenesupercapacitors to increase mobility.

As discussed above, the control module 70 may have a display screen 72,which display screen may be a capacitive sensing touch-screen display,for allowing a system operator to configure the various systemcomponents, such as to adjust the various settings of the tMS stimulator10. Likewise, the tMS device may be controlled through the controlmodule 70, or may itself include control buttons for controlling thesettings and other parameters of the device. In either instance, one ormore control instruments for controlling the settings of the tMS device10 may be provided, or a touch sensitive display screen may be providedfor controlling the settings and displaying various status and otherindicators.

Particularly, as described in greater detail herein below, a graphicaluser interface (GUI), such as for configuring and controlling thesystem, may be accessed via the display, such as where the display is acapacitive-sensing touchscreen display. The GUI may be presented at thecontrol module 70 or a third party control device, such as a display maybe on a client computing device, such as a smartphone. The GUI allowsthe user, e.g., a system operator or patient, to input the settings fortheir treatments and provide a pre-treatment pain score andpost-treatment pain score. The scores can then be correlated with theinput settings to determine which tMS settings provide the bestreduction in pain. Additional feedback from the subject to be treatedrelating to the treatment may be entered automatically, e.g., via voicerecognition, or by the system operator manually entering in to a notestab.

Likewise, as indicated, the display screen may be configured fordisplaying information on the positioning of the components of thesystem and information regarding the treatments being administered. Forinstance, the system may determine, and the display may present a screendepicting where all of the components our in space relative to oneanother, and/or may display tracking information so as to account forrelative motion of the components relative to that space, such as atracking distance to a target region. Likewise, the display at the GUImay present treatment parameters related to the tMS settings. Asindicated, the display screen, and representations of the buttonspresented therein, may be capacitive touch or capable of receiving othertouch inputs, so that the user can select the levels of the tMS devicesettings, including: frequency, duration, pulses, and amplitude.

As discussed, these settings may be entered at a controller of the tMSdevice 10 or may be entered at a separate control module 70. In eitherinstance, the control device may be configured for communicating thesesetting selections automatically from one to other components of thesystem, and may be presented for display thereby. For instance, the tMSdevice 10 may automatically transmit the current settings, during and/orafter a treatment session so the operator or patient can instantlyprovide feedback related to the session, which feedback can be enteredmanually or automatically into the system 1.

Accordingly, the graphical user interface may also allow the user tocontrol the tMS device 10 for executing a treatment session. Forinstance, a pain score interface may be displayed where the user inputsa pre-treatment pain score. Likewise, the interface allows the patientto input a post-treatment pain score. The differences between scores canthen be compared with the settings for the particular treatment todetermine how effective the treatment was at the particular settings.The operator or patient may add notes to further explain the reasons forthe scores or other information relevant to the treatment, and thesenotes may be transmitted to a healthcare professional along with thetreatment settings and pain scores, as will be described in furtherdetail below. Hence, as described below, the system 1 may be configuredfor receiving feedback, and making adjustment to system parameters withrespect thereto.

Additionally, not only may the system 1 be configured for receivingoperator or patient feedback, it may be configured for receivingcomponent feedback. For instance, the system 1 may include one or morefeedback devices. For instance, a feedback device may be a portablesignaling device that may be configured to be positioned on a moveablecomponent of the system and/or on or near a target site, for signalingto the system 1, where the components are and/or where a treatment areais. In various embodiments, the feedback device may be an electronicsignaling device, whereas in other embodiments, it may simply be areflective device. For example, in certain embodiments, the feedbackdevice may be a portable electronic device that is configured forreceiving data from the control module 60 and/or imaging component 30relating to the delivered magnetic pulse and/or direction oftransmission, and to generate feedback with respect thereto. The system1 may receive this data and correlate it with data received from asubject relating to the delivered magnetic pulse, such as data ratingthe subject's experience of pain and/or its amelioration at thetreatment area and/or at one or more treatment sites.

Hence, the feedback device may be configured for wireless communicationwith one or more controllers of the system, such as the control module,and thus, may be configured for receiving, generating, and transmittingfeedback, which feedback may be used by the system to change of modulateone or more control settings, such as relating to a treatmentparameters. For instance, in one embodiment, the portable electronicfeedback device may be utilized with the tMS device 10 and controlmodule 60 to provide for wireless control of the tMS device 10 andanalysis of treatments.

In particular instances, the system may be configured for receiving oneor more constructions from a third party computing device that may be incommunication with one or more components of the system. For example, athird party computing device may be a remote device that communicateswith the control module 70 of the system, and as such may be a mobilecomputing device, such as a laptop computer, a tablet computer or smartphone, or even a smart wearable device. Accordingly, the third partycomputing device may be configured to wirelessly communicate with thecontrol module 70 and/or positioning element 20 and/or tMS device 10, soas to provide control instructions to one or more system components.Particularly, the third party computing device may include a display,e.g., a GUI, that is configured for providing a visual interface fordisplaying information about the control of the system components,treatments performed thereby, and provide for inputs for the operator orpatient to interact with the system components. The third party controldevice, along with the feedback device, may be connected one with theother and/or to the system through a suitably configured communicationsinterface, such as via a wireless connection protocol, such asBluetooth®, Wi-Fi®, NFC, or a proprietary device-specific network suchas the 2net™ Platform® for wireless health, and the like. In oneembodiment, an internal modem with an omnidirectional antenna may beutilized to connect with IEEE 802.16 family wireless hotspots and 3Gtelecommunications networks such as WiMAX. These networks may beutilized to passively transmit usage data on the device to a remoteserver for monitoring the usage and performance of the device. Updatesto the settings, programs and configuration of the hardware, softwareand firmware may be provided over these networks, whether by atechnician who is improving the performance of the device or by aphysician updating a patient's treatment session parameters.

In various embodiments, the system 1 may include a guidance tool.Specifically, in various embodiments, guidance for proper positioning ofthe target region, such as for identification of one or more treatmentareas, can be provided by one or more, e.g., a combination, of markingelements that may be applied to the subject's skin, e.g., approximate atarget region. As explained below, the guidance tool may be a distinct,physical element that may be positioned on or near the target area, orit may simply be a mark provided by a marking material that is visibleor invisible or nearly-invisible under normal light conditions. Forexample, a fluorescent ink may be used, such as where the ink is visibleonly under focused UV light, e.g., a black light. In such an instance,the imaging component may include a UV light source, which light sourceis optically focused to coincide with one or more optimal flux locationsfrom the stimulation device. In one embodiment, the UV light source maybe an LED that produces light at around 400 nm, making it more compact,rugged and easily portable, while generating light that is near thelower end of UV wavelengths and, therefore, safer for repeated exposure.

In other embodiments, guidance may be provided by a tool for use indetermining the relative positioning of one or more of components of thesystem, such as for determining the relative position of the positioningelement 20 and/or the tMS device 10 with respect to the treatment area,including one or more treatment sites, of the body. Particularly, invarious embodiments, a guidance tool may be provided such as where theguidance tool includes one or more demarcation elements, such as alocating component, e.g., a light element, such as a light emittingdiode, capable of being tracked, a measurement sensor, such as formeasuring distance, and/or reflective element, so as to form a guidancematrix. For example, the guidance tool may be one or more of a lightemitting or reflective marking device. The light emitting and/orreflective marking device may be any element that includes one or morelight emitting or reflective elements that is capable of beingpositioned in such a manner as to define or otherwise demarcate thelocation or position of a treatment site, positioning element, and/or amagnetic coil of the system.

In a particular embodiment, the light emitting and/or reflective markingdevice includes one or more extended members, such as a plurality ofopposed extended arm members. Specifically, in various embodiments, themarking device includes a plurality of arm members, such as where eacharm member includes a proximal portion having a proximal end and adistal portion having a distal end. The arm members may be configuredfor being coupled to one another at their proximal ends, such as to formthe configuration of an “X”. Additionally, the marking device mayinclude a light emitting and/or reflective element positioned proximatethe distal end of each arm member. In such an embodiment, the markingdevice may be configured for being positioned at a target site that isproximal a location to be treated. In various embodiments, the markingdevice may be configured to aid in one or more of the positioning of thevarious components of the system with respect to one another, e.g., visa vis the targeting and/or treatment site, and may further aid indetermining a quality and/or directionality of the magnetic flux to bedelivered by the magnetic coil.

In various instances, the system 1 may be configured for not onlyadministering a treatment regime, including a series of magneticinduction administrations, but the system may also be configured forcollecting, analyzing, and/or tracking data. For instance, as indicated,the system 1 may include a computer or server, such as a local computingresource 70 or a remote cloud-based server 80, that is communicablycoupled to a database, such as a database that is configured for storingpatient data, such as for determining, monitoring, and tracking dataabout one or more patients.

Accordingly, in various embodiments, a system 1 for delivering magneticinduction, e.g., in the form of a treatment, such as by using a tMSdevice 10 as disclosed herein is provided. Hence, the portableelectronic tMS device 10 may include a communications module such as forcommunicating both with a controller of the device, a local computingresource 70 in communication with the controller, and in variousinstances with a remote server 80. The system, therefore, may beconfigured for treating a subject and communicating the data relatedthereto to one or more computing resources, e.g., remotely and/orlocally, where the data to be collected and transferred may be relatedto the patient and/or malady, e.g., pain to be treated, one or morecharacteristics about the treatment session, patient feedback about thetreatment and its administration parameters, such as device settings,magnetic wave dimensionality: frequency, amplitude, intensity, theconfiguration of the system, orientation of the positioning elementand/or its segments, e.g., its coordinates in 3-D space and/or itsrotations, orientation of the magnetic coil device, informationregarding the treatment and/or target site, its location in 3D space,the dimensionality of the treatment site, treatment depth, devicesettings, and the like. All of this data can be collected and can betransmitted to the local 70 or remote 80 computing source, such as forstorage and/or analysis.

In various embodiments, the data received at the remote server 80 may bestored in a database 81, where the data for individual subjects, e.g.,patients, or a group of subjects or other users, may be collected andanalyzed to determine the effectiveness of treatments on certain typesof subjects, body parts, treatment sites, pain, symptoms, etc. Likewise,the remote server 80 and/or local computing resource 70 may also beconfigured to transmit data to the tMS controller or magnetic deliverydevice 10. For instance, such data to be transferred back and forthbetween the various devices of the system include one or more oftreatment settings, treatment configurations, including distances andorientations, and the like. This data can be transmitted back and forthin order to provide current, updated, real-time treatment plans andsettings based on the patient feedback, thus avoiding the need for thepatient to visit the same healthcare provider at the same location, butrather, can visit any location anywhere in the world based on thecollected data from previous treatments.

For example, in various embodiments, the system 1 may include anapplication programming interface, API, so as to allow other systems toaccess and configure the tMS system components, and/or to configure thetMS system itself. In a manner such as this, a nationwide server systemmay be established whereby subject data from a plurality of remotetreatments sites may be collected, correlated based on one or morefactors, such as treatment site, quality of pain, effectiveness oftreatment, treatment parameters and the like, which correlated andanalyzed data may then be used to configure the system. This data may becollected and analyzed, such as by a suitably configured A/I module ofthe system, so as to determine optimal treatment parameters, forinstance, based on a statistical analysis of a plurality of patientsbeing treated. Optimal treatment parameters may be determined such asbased on the treatment for similar pain from similar conditions such asfrom similar treatment sites, where the system has determined thatvarious system parameters and configurations have been identified ashaving efficacy in a statistically effective manner, such as by beingeffective for the treatment of 75%, 80%, 85%, 90%, 95%, 98% of subjectshaving common characteristics as to quality of pain. Accordingly, thesystem may be configured for receiving a plurality of data from aplurality of treatment locations for a plurality of subjects beingtreated over a plurality of sessions, and for analyzing that data todetermine optimal treatment characteristics and procedures, whichoptimal procedures may then be communicated back to the local tMSsystems so as to calibrate and set the local parameters for treatmentbased on the identifiable pain and/or treatment site characteristics andthe like.

Another component of the system, therefore, may be a workflow managersystem (WMS), which may include an API configuration, wherein the WMS isconfigured for assessing incoming treatment requests, indexes one ormore treatment jobs to be performed, forms a queue, allocates theresources, e.g., tMS device allocation, and generates a pipeline fortreatment flow, such as where a central facility is controlling theoperation of a multiplicity of local tMS systems. Accordingly, when arequest for treatment comes in to the system 1, either for local orremote treatment, and is preprocessed and queued, an instance, e.g.,computing resource, allocator may then spin up the various treatment jobdevices in accordance with the queued treatment projects. Hence, oncethe various treatment projects are indexed, queued, and/or stored in anappropriate database, the WMS will then pull the determined optimaltreatment data from storage, cycle up an appropriate instance, whichretrieves a treatment file for the subject, such as based on acharacterization of their pain, or a previous treatment regime, and maythen run the appropriate processes on the data to perform one or more ofthe requested treatment jobs.

Likewise, once the treatment has been performed and/or feed back fromthe subject regarding the treatment has been obtained, then the resultsdata may be collected, compressed, if desired, and stored, such as in anappropriate memory instance, e.g., a first data base. These results datamay then be analyzed by the system and one or more new treatmentparameters may be determined and used to adjust the optimal treatmentparameters, which new optimal treatment parameters may then be used forthe next treatment regime to be administered to the same or a newpatient. Further, as new treatment requests come in and/or current jobsare being run, the workflow management system will constantly beupdating the queue and optimal treatment parameters (real time) so as tocontinuously be updating the various different tMS devices of the entiresystem 1 so that at any given time any given tMS device 10 may beimplementing the most up to date treatment parameters, so as to keep thedata flowing through the system and the processes of the system runningefficiently. Accordingly, the system 1 may constantly be taking theresults data and storing the data in a local and/or a remote database,prior to further processing and/or transmission, such as transmissionback to the central server 80. The generated results data files whencompressed and/or stored may include appropriate meta data and/or otherassociated data, which associated data may be different for data to bestored versus data as it flows through the system.

Accordingly, the devices and systems presented herein may be implementedfor the purposes of effectuating one or more, e.g., a variety of,treatment protocols. For instance, the devices and systems of thedisclosure may be employed for the purpose of treating pain, such aschronic pain, for instance, chronic pain caused by damage or otherinjury to one or more nerves. Specifically, in an exemplary method, thedevices and systems of the disclosure may be configured for treatingneuropathic pain, such as for providing tMS to a treatment siteexperiencing pain.

Particularly, in a first step, a tMS system 1 including a tMS device 10may be provided, such as for the administration of therapeutictreatments. The tMS system, as disclosed with respect to FIG. 1, mayinclude a control module 70, a tMS device 10 having a magnetic inductionapparatus 15, a positioning element 20, an imaging or tracking component30, and/or one or more other components of the system disclosed herein.Once provided, the device operation settings of the control module maybe configured, manually or automatically, such as in accordance withdetermined optimal administration parameters, for a treatment session.The treatment parameters may be determined, as discussed above, and maybe specific to the subject to be treated, and may include the frequency,duration, pulse, and amplitude, of the tMS device, as well as theconfiguration of the positioning element, which parameters may have beendetermined to maximize efficacy.

Once the system and/or device parameters have been appropriatelyconfigured, the target site may be defined, as described in detailbelow, and then the tMS device 10 may be positioned proximate thetreatment site, such as via the manipulation of the positioning element20. Specifically, the tMS device 20 may be positioned in proximity toone or more of a target and/or treatment site via the manual and/orautomated movement of the positioning element 20. For instance, based onprevious treatments of this particular subject, or a set of optimalparameters determined based on a plurality of patients previouslytreated with the same or similar pain experience, treatment site, nervedamage, and the like. Alternatively, the positioning may be determinediteratively, as explained in detail below, such as through a process ofsteps by which the ideal treatment arrangement for this patient at thistime may be determined.

Accordingly, once the target and/or treatment site has been determined,the positioning element may be arranged and/or orientated so as toposition the magnetic coil 15 of the tMS device 10 adjacent to a bodypart that has been identified for treatment, such as in a previous step.In various embodiments, the positioning may be performed by using one ormore of the positioning aids described herein. Likewise, once the tMSdevice 10 is positioned, the treatment session can be started. Before,during, and/or after a treatment session, feedback may be obtained fromthe patient, such as by eliciting verbal feed back, measuring feedbackfrom the body, determining feedback from one or more of the systemcomponents, such as from one or more sensors of the disclosure. Suchfeed back can be recorded by the system, such as at the control module70, and can be used to determine optimal administration parameters suchas to ensure that the device and/or its components are performingadequately and that the user is experiencing a decrease in pain. Invarious instances, the feedback may be transmitted to a remote locationor stored locally for analysis, and if necessary or otherwise desired,the plan for administration and treatment, and/or the device settingsand/or configurations may be adjusted as a result of the feedback and/orits analysis.

In various embodiments, the system may be operated according to one ormore of the following steps: The system first may be setup, the variouscomponents of the system and system parameters may be arranged and/orotherwise configured, and the functionality of the system and itscomponents may be verified. For instance, prior to or during use of thesystem, the positioning element 1, such as the robotic system, may besetup, the control parameters and/or the robotic arm positioning may beconfigured, and the system functionality can be verified by one or moreprocedures so as to ensure the positioning and administration systemscan successfully execute the therapeutic treatments.

In a particular instance, the stimulatory apparatus encasing themagnetic coil, e.g., a butterfly coil, may be moveably attached to thepositioning element, such as at or near a proximal end thereof, such asa tool end of a positioning element, such as configured as a roboticarm. Specifically, as can be seen with respect to FIG. 1B, the tMSdevice may be mounted, e.g., in a precise fashion, to a fixture of thedistal portion of one of the segments of the positioning element 20. Forinstance, the positioning element 20 may have a plurality of segments 20a, 20 b, which are configured for being moveably coupled to one anothersuch as via a moveable joint. In some instance, the joint member mayinclude a motor 21 a, 21 b, 21 c, which motor may be configured forenabling movement within the plane and/or for rotational movement. Thedistal end of the positioning element 20 may include a couplingmechanism, such as an attachment fixture. Particularly, the attachmentfixture may be configured for removably coupling to the positioningelement 20 with the tMS device 10, such as via any suitable attachmentmechanism, such as by bolting directly to the fixture or via anintermediary tool flange, such as where the geometry of the fixture andposition of the tMS device 20 in relation to the positioning element 20,e.g., robot, tool end is known.

Once the system is setup, then the target area may be configured and/oraligned. For instance, a target area search sequence may be initiated,and then a target area tracking procedure may begin. Specifically, withrespect to system setup, configuration, and functionality one or moremarking or signaling indices may be employed, such as one or morepassive or active indicating markers, such as a reflective marker and/ora lighting element. As indicated above, a passive or active marker 22may be removably coupled to any or all of the components of the system,so as to define their position in the defined 3-Dimensional treatmentspace.

Accordingly, in some embodiments, a marking device, such as a reflectiveinstrument or a lighting element may be attached to one or more of thefollowing areas: on one or more of the segments of the positioningelement, such as at the end regions of one or more of the articulatingsegments, such as at a joint position and/or where an automatingelement, e.g., a motor unit, is positioned, such as at a base of arobotic arm, at a position proximate to where the robotic arm couples tothe tMS device, or at a location positioned somewhere in between. Forinstance, as can be seen with respect to FIG. 1B, a positioning element20 of the system 1, configured as a robotic arm, is set forth, where therobotic arm 20 includes a plurality of segments 20 a, 20 b, whichsegments are coupled together at a moveable joint region that allows thetwo segments to move with respect to one another along one or moreplanes of motion, and/or may be configured to rotate around an axisdefining one or more of those planes.

Also included is a terminal member positioned at a distal portion of therobotic arm 20, to which terminal member the tMS device 10, includingthe magnetic coil 15, the distance scanner, and/or an imaging element,such as a camera may be attached. For example, an imaging device(s),e.g., camera, may be coupled to one or more components of the system,such as to a housing the tMS device 10, or may be a free standingelement 30 that is a separate instrument from the tMS device 10 andpositioning element 20. As indicated above, the camera may be astereoscopic camera that is configured for imaging a three-dimensionalspace, e.g., of the treatment site, and with the appropriateconfigurations can image a three-dimensional space of the subject'sbody, which three-dimensional space defines the treatment site withinthe body of the subject, thus providing a three-dimensionalrepresentation of the treatment site from within the body.

As can be seen with respect to FIG. 1B, the robotic arm 20 includes amarking device 22 a, in this instance, at the base of the robotic arm,by which the system 1, e.g., via one or more of the imaging component 30and/or distance scanner 40, can track the movements and positions of thepositioning element. In certain instances, the marking device includes afirst set of marking elements, such as including a plurality, e.g., 3,three reflective elements. Additional marking devices may also beincluded such as a primary and a secondary or tertiary reflecting and/orlighting device.

For instance, as depicted here, a plurality, e.g., three, sets of markerdevices, 22 a, 22 b, 22 c are useful for defining a three-dimensionalspace and/or where one or more of the components of the system ispositioned within that three-dimensional space, and for trackingmovements and orientations of the various elements of the devices, suchas with respect to the position of a treatment site of a subject toreceive treatment. The geometry of each marker may be uniquelyconfigured so as to function along with the three-dimensional camerasystem 30 so as to define the three-dimensional treatment space and/orto track the movement of the positioning element 20 within that space.Reflective markers and/or lighting elements or other sensing units mayalso be used to determine the position and/or orientation of the tMSdevice 10, e.g., the magnetic coil 15. For instance, the tMS device 10and/or the positioning element 20 may include one or more sensors thatare configured for generating data that may be used for determining theposition and/or orientation of one or more segments of the positioningelement and/or the tMS device and/or imaging component. Such sensors mayinclude a gyroscope, an accelerometer, a light sensor, a pressuresensor, and the like.

Accordingly, there are a variety of marking devices that may be employedin the system, such as marking devices configured for being coupled tothe positioning element 20 and/or tMS device 10, e.g., so as to definethe space which the positioning element and/or tMS device occupies, andtarget site marking devices, which may be configured for defining orotherwise demarcating the site to be treated. Specifically, suchtreatment area markers may be positioned on the patient so as to definethe target area, such as after a suitably configured target searchprocedure has been completed.

In various embodiments, a calibration procedure may be implemented so asto determine the baseline, e.g., home or at rest, positions of thesystem components. For instance, a first calibration procedure may beimplemented such as a positioning element 20 (e.g., a base and/orsegment or joint positioning element) to imaging element 30 calibrationprocedure may be implemented, so as define the initial position betweenthe positioning element 20, e.g., robotic arm, and the imaging device30, e.g., camera, such as for the purpose of calibrating the systemcomponents. Specifically, each of the positioning element segmentsand/or joint elements having a marking device positioned thereon may befirst placed into their home position, e.g., manually or automatically,such as by initiating a homing sequence program implemented by a localcomputing resource in communication with the controller of the systemcomponents, e.g., via a suitably configured GUI of a display associatedwith the local computing resource.

Next, the imaging device 30 can be positioned to have the positioningelement marker(s) 22 a, e.g., base marker, in its field of view andwithin its measurement volume. From this position the rotational angleof the X, Y, and/or Z-axis may be determined, such as by reading thepositioning element marker coordinates from the camera in order tocorrelate the positioning element and imaging device coordinate system.

Further, as discussed above, a distance determining device 40, such as adistance scanner may be included as a component of the system 1, such aswhere the distance scanner 40 may include a micro distance measurementsensor. In various embodiments, the distance determining device 40 mayinclude one or more laser sensors. For instance, a distance determiningdevice 40, e.g., having a micro distance measurement sensor, may be afree-standing component 40 or may be coupled to one or more othercomponents of the system, such as to a tMS device 10 or an imagingdevice 30. For example, the distance determining device 40 a, e.g., thedistance scanner, may be removably coupled to the housing of the tMSdevice 10, and/or may be a plurality of elements that are positionedproximate a magnetic coil 15 of the tMS device, such as between thecoils of a butterfly or FIG. 8 coil, or positioned around thecircumference of one or more of the coils. Specifically, the distancescanner 40 may be attached to the housing of the tMS device 10, such asto be attached in a position that is proximate to the butterfly coil, soas to be able to determine one or more of the distance of the coil fromthe target site and/or body of the subject to be treated, and/or to beable to determine the orientation of the magnetic coil 15 and/or the tMSdevice 10.

As can be seen with reference to FIG. 2A, the distance scanner 40 a canbe positioned at a known, precise location, such as by using a bracketcoupling mechanism, an adhesive, or other suitable coupling mechanism.Particularly, distance scanner 40 a, or other distance determiningsensor, can be mounted closer or further from the tMS device 10 andmagnetic coil 15, such as from about 1 to about 5 mm, from about 6 toabout 15 mm, or more than about 16 to about 30 mm to about 40 or toabout 50 mm away from the coil 15, such as to eliminate malfunction ofthe sensor due to magnetic field interference, or alternatively thesensor may be insulated to prevent such interference. Where anattachment member is employed as a coupling device, such as a bracket,the various members of the coupling device can be substantiallyidentical so as to allow for easy calibration/integration into thesystem.

More particularly, the distance determining device 40, e.g., scanner,can be mounted or otherwise coupled to the housing of the tMS device 10in a variety of positions as set forth in FIGS. 2A and 2B. For instance,as can be seen with reference to FIG. 2A, the scanner and/or sensor 40 amay be positioned at Position A, B and/or C, such as depending on thelocation and/or configuration of the treatment area, such as dependingon a location determined to allow the sensor(s) to generate the mostcomprehensive and accurate position and orientation data for the tMSdevice 10 with respect to the target and/or treatment sites demarcatedon the subject to be treated. For example, the tMS device 10 may includea single distance scanner 40 a that is positioned around a circumferenceof the tMS device, e.g., as exemplified by positions A, B, or C, (or anyposition in between), or a plurality of distance scanners may beincluded and positioned in multiple locations, 2, 3, 4, 5, etc. aroundthe circumference of the tMS device housing. Additionally, althoughillustrated being attached to the tMS device via a bracket, in variousembodiments the distance scanner can be attached directly to the tMSdevice, and in various embodiments, a distance scanner can be positionedbetween two magnetic coils or around a circumference of one or more ofthe magnetic coils. Further, as illustrated in FIG. 2B, the distancescanner 40, e.g., including a laser sensor, may be mounted to the tMSdevice housing, such as by an intermediate mounting bracket, in a mannerso that the sensor is positioned a given distance from the housingand/or a boundary of the magnetic coil, in this instance, 30 mm from thehousing.

The distance determining device 40 may include a communications and/or asource of power, e.g., a rechargeable battery or other energy reserve,and as such the distance scanner, or any other component of the system,may be configured for wired or wireless power supply and/or recharging,e.g., of an included battery, and/or for wired or wirelesscommunications. For example, the sensor device may be electrically andcommunicably connected, e.g., in a wired configuration, to the tMSdevice and/or positioning element, such as via an I/O connector. In suchan instance, this wired connection may provide 24 VDC power to thesensor module and may use analog input to read in distance measurementvalues. In other embodiments, digital distance measurement data may begenerated and communicated digitally, such as via one or more wirelesscommunication mechanisms as discussed herein.

Together the distance determining device 40 and/or the image capturingdevice 30 may be employed to track the movements and positioning of thepositioning element 20. For instance, the imaging capturing device 30may be used to define a three-dimensional space within which thepositioning element 20 operates, and the distance determining device 40a, 40 b may be employed so as to determine the position and/or theorientation of the tMS device 10 and/or magnetic coil 15 thereof, asdepicted in FIG. 3. In such an instance, the system itself, such as viaa suitably configured A/I module of the system, may be employed todetermine the space and optimal positioning of the system componentswithin that space, such as relative to the target site (see FIG. 4), forthe effective delivery, from the magnetic coil 15, of a magnetic fieldsufficient to treat a subject suffering pain at the treatment site.

In other instances, this configuration and orientation may be determinedco-operatively or manually, such as via the input of an operator,clinician, or other system and/or device operator. For example, theclinician/operator may enter various distance values, such as a minimumor maximum distance value, e.g., for all coordinate dimensions of thetreatment space, so as to define the tracking region for the positioningelement and/or the tMS device. Hence, this dimensionality, e.g., theminimum/maximum distance value, may be applied to each direction X, Y,and Z, so as to from a digital, e.g., mathematical, representation ofthe three-dimensional treatment space within which the componentsfunction, such as to track the movement of those components through thetreatment space. Specifically, the minimum and/or maximum distances,e.g., in mms or nms, can be determined and specified from any origin,but typically will be defined with its center being the center of thetarget area and/or treatment space. More specifically, one or more,e.g., all, of the markers within the tracking region and/or treatmentspace may be characterized and defined, and then the boundaries of atreatment site, and a tracking region within that treatment space, maybe determined so that the movements of the various components of thesystem may be within the allowable measurement volume of the imagingdevice(s), e.g., during all times of therapy. It is useful for thetracking region to be within the workspace of the positioning element.

Particularly, as can be seen with respect to FIG. 3, during therapy, thepositioning element 20 will move the tMS device 10 so as to position thetMS device 10 so that it is proximate the determined treatment site, andonce there, may make adjustments to the position and/or orientation ofthe coil 15, such as by tracking the of one or more of the positionmarking devices 22, such as one or more marking devices 22 a on thepositioning element, at the treatment area, and/or a marker on the tMSdevice, so as to determine their coordinates in the treatment area, andto determine and assign distance measurement as well as coordinatevalues to each component of the system 1. For instance, positionadjustments may be executed within the defined treatment space, such aswithin a determined tracking region within that space. In variousinstances, a potential movement outside of the defined region and/ortreatment area may be prohibited by the system, either mechanically orelectronically. More particularly, if a target area tracking results inadjustments outside the tracking region the positioning element, e.g., arobotic arm, will stop movements at the boundary of the tracking regionand/or treatment space.

Accordingly, the system 1 may be configured for tracking the movementsof the positioning element 20 within a defined space and relative to thesubject. For instance, the 3-D space may be configured for determiningand defining the boundaries of the 3-D space, and further defining thetracking region within that space. Particularly, as indicated, one ormore segments of the positioning element 20 may include a reflectivemarking instrument 22, and/or the image capturing device 30, e.g., 3-Dcamera, may also include a reflective marking instrument or other sensor40 b, e.g., position determining sensor, such that movements of thepositioning element 20 relative to the movements of the camera 30, ifany, can be determined and tracked. In certain instances, the markinginstruments may include one or more sensors that are in communicationwith one another, so as to communicate relative positioning one to theother. Particularly, the 3-D camera 30 may have a sensor 40 b that iscapable of communicating with the sensor 40 b, e.g., marking device onthe positioning element. In such an instance, the 3-D camera positionsensor may be configured and positioned so that the various markingdevices, e.g., on the positioning element and/or on the patient, at thetarget site, are within the defined treatment region, e.g., duringoperation of the tMS device 10, such as during target area tracking.

Specifically, prior to the initiation of treatment, and after definingthe treatment region, verification of system functionality may beconducted. For example, the system control can verify the following:That the positioning element and control module are powered on and readyfor use. The image capturing device is powered on and ready for use. Thedistance determining module, e.g., containing a laser distancemeasurement sensor, is powered on and ready to use. And the tMS deviceand magnetic induction element are powered on and ready for use.

Once the system is appropriately configured and its components set upand powered on, a target area alignment procedure may be implemented. Insuch an instance, a device operator, such as a clinician, may manipulateone or both of the positioning element and the attached tMS device,including the butterfly magnetic coil to the desired target area, suchas manually, when the positioning element, such as a robotic arm, is infree-drive mode. However, in various instances, the system may beconfigured for moving the various components thereof automaticallyand/or autonomously, such as by the control unit of the system, inconjunction with the imaging component, driving the motors of thepositioning element and/or tMS device into the appropriate positioning.In particular embodiments, this may be accomplished further inconjunction with a suitably trainer artificial intelligence unit and/orvirtual reality element of the system.

As depicted in FIGS. 4 and 6B, to aid in this positioning, the systemmay generate a distance measurement display that is configured to showthe coordinates of one or more of the segments of the positioningelement and/or the tMS device within a defined treatment space, and/orwith respect to a measured distance from a treatment site. For instance,the system may include a graphical user interface that is configured forbeing presented at a display of the system, such as a display associatedwith a computing unit 70, where the graphical user interface displaysone or more distance measurement values, such as obtained from one ormore of the distance sensor and/or imaging component, and which can beused, either by the system or manually, as a guide for positioning andalignment. In various instances, this may be used, such as by theclinician, in manually positioning the positioning element 20 and/or thetMS device 10.

For example, various of the components of the system may include one ormore distance scanning lasers 40 that are positioned so as to determinewhere any given element is positioned within a defined space and/or withreference to a target area, such as adjacent to a treatment site. Thesensors can communicate amongst themselves, one or more of thecontrollers, and/or the imaging component so that the movement andorientation of the various components of the system may be tracked, suchas in relation to a coordinate system, defining positions and distances,e.g., in three-dimensional space, and/or can be used to build a virtualspace electronically that can be digitally represented at the GUI of thesystem, within which the various components of the system may further bedigitally represented and their movements controlled and/or tracedwithin the virtual space. In various embodiments, the system can use thevirtual space to automatically move the system components to thedetermined treatment site at the generated optimal distances.

Accordingly, in various instances, the various components of the systemmay include multiple distance scanners, e.g., lasers, that measuresdistance changes over a defined space so as to determine how far a firstpart of the system component is from one part of the target site, andfurther how far a second part of the system component is from a secondpart of the target site, e.g., on the body of the patient, such as wherethe body part to be treated is curved, such that positioning element andtMS device can be positioned to accommodate supply treatments to thebody part while yet accommodating different body topologies. In variousembodiments, the housing and components of the tMS device 10, includingthe magnetic coil 15 therein, is configured for being configurable, suchas where the right hand side of the tMS device, e.g., the RH coil, isconfigured to be moved and orientated with respect to the left hand sideof the tMS device, and vice versa. Once the positioning element 20 andthe tMS device 10, including the magnetic coil 15, has been grosslypositioned within the target area, near the target site, then a finemotor movement protocol can be initiated so as to finely move thepositioning element and for orientating the tMS device 10 so as to be ina close position to the target site, such as for effective and efficientdelivery of treatments, e.g., magnetic fluxes, to the site of treatment.

Accordingly, once moved generally to the target area so that the deviceis within the desired location, then the clinician or other operator canstart the target area detection and fine-tuned alignment sequence, andthe refined treatment area alignment can be defined. The treatment areaalignment may define the work plane the device will move in during thetarget area detection sequence and tracking.

For instance, as set forth in FIG. 4, a target area and treatment sitedetection sequence is provided. When initiated, the target and/ortreatment area detection sequence will either automatically move ordirect the clinician in moving, such as via providing an indicatingfeedback, e.g., visually, vibratory, tonally, or the like to theclinician while manually moving the components, such that the coil ismoved along the work plane, such as in a predetermined grid pattern, toprecisely determine the target area and define one or more particulartreatment sites. Particularly, the tMS device 10 may be powered on alongwith one or more associated distance measuring scanners 40, and may beorientated toward the target area such that distance measurements fromone or more portions of the tMS device housing and/or coils 15 is takenwith respect to the body to be treated, such as within the target area.

More particularly, a generalized optimal target distance may begenerated beforehand, which may then be entered into the system so as todefine a general target area, within which target area a more refinedtreatment site may be defined. Hence, the system itself or a clinicianor other operator of the system may then determine one or more coil totarget distances. In one embodiment, the system or the clinician candetermine and specify a first coil to target distance value, which maythen be used by the system to define a target area parameter, which maythen be presented for observation on the GUI. During the target areaand/or treatment area detection and target tracking procedure, thegeneral position of one or more of the positioning 20 and/or tMS device10 may be maintained, and the distance between the bottom of the tMSdevice housing and/or individual coils 15 and the target area, e.g.,using a feedback signal from the distance sensor 40, may be determinedand a treatment area defined thereby.

A tMS device and/or coil to target site distance tracking and/or coilalignment may be performed, such as where the tMS device and/or coil totarget site distance may be defined. This may be done in a manner thatthe distance between the bottom of the coil and the point where thedistance scanner detects the skin within the treatment area is defined.This general procedure is exemplified in FIG. 4, where the tMS device 10including a distance scanner 40 a, e.g., a laser, is positioned abovethe skin near a target area, at a first determined distance away fromthe skin, such as where the distance is defined by the distance measuredbetween the target skin surface and the bottom of the tMS device and/orcoil. The device 10 may then be moved across a selected area so as todefine a particular target site.

Accordingly, once the target area has been more precisely defined, thenthe target site can be determined, and from that target site, a firsttreatment area may be determined, and finally, one or more treatmentsites may be defined. During a treatment area search and target trackingprocedure the tMS device and/or coil may be adjusted, e.g., in the X, Y,and Z directions, to track the treatment area and maintain desireddistance, and once the target site is defined, then a treatment area maybe determined, and/or a treatment site derived thereby. In suchinstances, the device components may be manipulated within the treatmentarea so as to determine not only the appropriate treatment distance, butalso the treatment orientation of the device, and in order to do this,the tMS device and/or positioning element may be moved and/or rotatedabout the X, Y, and Z planes and/or axes so as to appropriatelyorientate the magnetic coil to the treatment site for the delivery oftreatment. Accordingly, once the target area has been bounded and atarget site identified and defined, then a treatment area may bedefined, form which a treatment site may be determined, such as in agrid search type sequence.

Specifically, as set forth in FIGS. 5A-5D, a grid-type search sequencemay be implemented. For instance, starting with the outer bounds of adetermined target area, a grid area representing the target site may bedefined. The grid may include a plurality of rows and columns offsetfrom one another so as to define a set of boxes having a determinedarea. Any number of columns and any number of rows may be used to defineany number of boxes, such as where the boxes are dimensioned so as todefine target site, which target site can define the area wherein asubject is experiencing pain to be treated. However, for the ease of usethe rows and columns define a grid, such as a grid of squares, whereeach square is made up of sides having substantially equal lengths.These lengths may be of any length from nm to mm to cm and/or to inches,feet, and meters, etc. depending on the type of pain and the areaaffected.

Nonetheless, in various instances, the grid includes three columns andthree rows together which form a larger box, but any number of columnsand rows may be employed such as 2, 4, 5, 6, and the like. In particularinstances, each side of each box will have a length of about 1 to 5 toabout 10 nm to about 1 mm to about 10 mm to about 1 cm to about 10 cm ormore. As depicted the length and width of each box is 3 mm, which meansthat the collection of boxes has a length of 9 mm and a width of 9 mm.As indicated, this overall box forms a search grid within which thepositioning element and/or tMS device may be finely moved and operatedin a manner so as to define a treatment area, wherefrom within thetreatment area, a more finely defined treatment site may be determined.

For instance, as depicted in FIG. 5A, a representation of a grid, havinga box-like configuration is presented. In this instance, the gridincludes 3-rows and 3-columns which make up a total of 9 boxes, which 9boxes together define the target area. As represented, each box has alength and a width of 3 mm, this defines 9 different areas, 1-9, whichcan then be tested, iteratively, to determine whether and/or to whatextent a nerve underlying the target area is reactive to a treatmentapplied by the system herein to the skin of the subject, such as theskin represented by one or more of boxes 1-9.

Hence, for the purposes of defining a target area from which a targetsight may be defined, and once defined a treatment area, from which atreatment site may be determined, the tMS device and/or positioningelement may be moved in accordance with a defined grid-like pattern,such as sequentially from areas 1 to 9, so as to determine the bounds ofthe area(s) to be treated. Accordingly, a grid search sequence can beinitiated, such as starting from an initial area, e.g., box 1 in thetarget grid, whereby the area represented by box 1 can be tested todetermine if any nerve cells within that area are reactive to theapplication of the therapy. Specifically, the positioning element may bemoved and/or otherwise manipulated so as to align generally with thearea represented by box 1, and once aligned therewith, the device may beoperated in a manner so as to test area 1 in order to determine thelevel of reactivity, with respect to pain remediation, that results fromapplying an initial treatment to the area.

If the area is to some extent reactive, e.g., the subject experiences adecrease in the feelings of pain when a magnetic flux is applied to thearea, then this may be indicative that the pain causing nerve may bepositioned internally at least within this area. In such an instance,the area represented by box 1 may then be demarcated for further testingto determine if that area should be included in an initial treatmentarea. For instance, if a magnetic flux is generated and targeted at theskin area represented by box 1 aligns with a configuration of the nervecausing the pain, e.g., in such a manner as to activate the nerve fiber,an amelioration or at least a diminution in pain will be experienced.This diminution of pain, therefore, would identify area 1 as being partof the locus of pain that defines the treatment area. However, if thenerve causing the pain is not significantly projected in this area, thenthe magnetic stimulation will have no effect on the nerve and there willbe no concomitant diminution of pain. Thus, area 1 may then be excludedfrom the to be determined treatment area.

Once box 1, representing a first area, has been tested, from there thedevice may be moved to align with the area represented by box 2, andarea two may then be tested. This process may then be repeated so as bymoving from one area to another incrementally, in any logical (orrandom) order so as to test each area represented by the grid-likestructure. For instance, each box may be tested such by moving thepositioning element and/or tMS device, such as in planar and/orrotational movement with respect to the skin of the target area. Once soaligned, then the tMS device may be operated so as to generate anddirect a magnetic flux toward the targeted area, e.g., with a given wavecharacteristic expected or known to be able to generate a response in asensitive nerve fiber.

If the area tested is sensitive to the treatment, signified by paindiminution, then it can be demarcated so as to be included in an initialtreatment area, whereas if the area is not sensitive to the treatment,then the area can be excluded from the to be defined treatment area. Thetreatment area, therefore, can be defined by selecting the boxesrepresenting areas in the grid that have proven to be sensitive orotherwise reactive to the inductive magnetic field, which areas,thereby, define the configuration of the underlying nerve to be treated.In various instances, once the treatment area has been defined, thisarea can be further tested so as to confirm the presence of theunderlying nerve to be targeted, such as by performing an intra-tissueimaging procedure, such as MRI, fMRI, etc.

Accordingly, in various embodiments, in testing the grid-like targetarea to define the configuration of the treatment area (and/orunderlying nerve to be treated), one or more target areas may be tested,as described herein, and when identified as being reactive to thetreatments, then the box demarcating that area may then be included forfurther testing. In this manner, the boxes to be included for furthertesting may collectively form a given configuration, such as aconfiguration that includes a plurality of boxes. Specifically, acollection of reactive boxes may form a pattern, such a vertical orhorizontal or diagonal row-like pattern. Particularly, this pattern maybe indicative as to how the underlying pain causing nerve is configured,such as if its fibers are aligned horizontally, vertically, ordiagonally. Other configurations may also be present, such as where theboxes show a branched configuration, such as where boxes 1, 3, 5, and 8are implicated as being sensitive to the treatment administrations. Ofcourse, other patterns can be evidenced based on the branching of thenerve tissue.

Therefore, in determining one or more of a target or treatment area, thesystem devices, e.g., the positioning element and/or tMS device, may bemoved, e.g., incrementally and/or sequentially, so as to test the entiretarget area, such as in a grid-like pattern, in a manner to determineone or more target sites to be further tested. For instance, asrepresented in FIG. 5A, a first pass of analysis may be performed by thesystem so as to determine the range of the target area, such as definedby a grid of boxes representing areas 1-9, where the target area can beconfigured to cover a 9 mm×9 mm section, such as where each box is 3 mmin length and width. In such an instance, an initial starting area maybe selected, e.g., from boxes 1-9, and the positioning element and/ortMS device may be moved from box to box in such a manner as to positionthe tMS device proximate the box representing the pre-defined skin areato be tested. A test signal, e.g. burst of magnetic flux, can beapplied, and a response may be evoked in the body and evaluated withrespect to its level of reactivity. If reactivity is detected, then thebox representing the area of reactivity can be demarcated as a treatmentarea that can be subjected for further testing.

Accordingly, in this manner, a sequential positioning and testing cantake place where the testing follows a specified grid-like pattern, forthe purpose of determining one or more treatment areas, from which area,one or more treatment sites is determined. For instance, as depicted inFIG. 5B, through the iterative process of positioning the tMS device todeliver a magnetic pulse to each target site within the target region,and determining the reactivity of one or more underlying nerves therein,one or more treatment regions, in this instance area 4, can be selectedfor further testing, so as to determine one or more precise treatmentsites, such as by subjecting the determine treatment area, e.g., area 4,to a second pass of the system.

For example, one or more passes, such as both a first, a second, and/ora third pass, may be initiated and implemented through interfacing withthe system GUI, through which GUI the various dimensionalities of thegrids may be determined. Specifically, as seen in FIG. 6A, a first userinterface, e.g., a start screen, can be provided where a user can accessand configure the system for use. The system, therefore, may have aplurality of modes of operation from which the user may select:including the running of an alignment or calibration operation,selecting a manual or automatic operation mode, for saving theconfigurations for a given position or location of targeting ortreatment, and/or for loading a previous saved positional configuration.A status of operation may also be indicated from this screen, such asfor indicating the status of connectivity and/or readiness for use,e.g., for the positioning element 20 and/or the tMS device 10 and/ordistance scanner 40 and/or force-torque sensor, and the like, todetermine if the various system components are ready for use, in use, inthe home position or targeted position, or if the positioning element inin free-drive mode. A fault level and present coordinates, includingdistance range, may also be shown.

A status indicator for the force-torque, or other pressure sensor, mayalso be included, such as for showing the status of connectivity, theset-point for the sensor, and/or if the limit has been exceeded.Likewise, a status indicator for the imaging element, e.g., a camera, ofthe system may also be presented, which status indicator can include astatus of connectivity, e.g., of the camera to the system, theconnectivity of the camera to one or more of the electronic and/orreflective marking devices, and/or whether they are in view of thecamera. If such connectivity fails, the system may automatically seek toreconfigure itself to re-gain connectivity, or may signal an alarm so asto allow an operator of the system to manually reconfigure the systemcomponents so that they are in an appropriate working configuration.

FIG. 6B depicts a home screen of a user interface, which home screen canbe accessed by interfacing with the start screen, wherein the homescreen presents a list of operations that can be selected to be run bythe system, such as a homing, aligning, calibrating, and/or trackingoperation may be selected to be run. A set-point screen can also beaccessed via the home screen, whereby the various set points of thesystem can be set. The current system status may also be presented, suchas where the current accuracy is set forth, the tracking rating andalignment can be demarcated, and/or the current distance between thetarget and/or treatment sites and the positioning element and/or tMSdevice may also be displayed. Control features may also be presentedsuch as a virtual start, stop, and/or a pause button, such as forcontrolling the operations of the system. An emergency stop and/orwithdraw button may also be presented, which emergency stop button maybe used to stop system functioning and/or return the positioning elementto the retracted, home position. A targeting and/or treatment matrix,e.g., grid, may also be presented, whereby the present sector being orto be targeted and/or treated may be presented and/or indicated on thehome screen, or the actual tracking grid can be accessed. This grid maysimply indicate the current tracking and/or aligning status of thesystem with respect to the targeting and/or treatment area, or the gridmay be configured for allowing the operator to manually enter the areato be targeted and/or treated, such by clicking on the demarcated area,as explained in greater detail below.

FIG. 6C depicts a set-point screen, such as may be accessed via the homescreen. The set-point screen may present various different systemparameters that can be set so as to appropriately configure the system.For instance, the set-point screen may present a tracking and/ortreatment region set point, such as for setting a dimension for an areawithin which the treatment is to be performed, and/or may include a coilto target distance set point, such as for setting a distance of the tMSdevice, e.g., magnetic coil, to the area to be treated. Other set pointfactors may also be presented such as for determining the dimensions ofa targeting and/or treatment area, such as within which one or moretargeting and/or treatment protocols may be implemented, such as tofinely define the treatment site.

For instance, as explained herein, the positioning element may be movedin three-dimensional space within an area of treatment, such as an areawithin which the movements of the device and subject of treatment may betracked. Hence, this space may be defined by the subject to be treatedand the devices of the system. Particularly, by entering thedimensionality of the tracking and/or treatment space, therefore, theoperator can define the treatment area, specifically, the minimum and/ormaximum distances the positioning element and/or tMS device can movewithin the treatment space. Likewise, as discussed, once a treatmentarea has been determined, then the treatment site may be determinedthrough an iterative process of experimentation, so as to define theregion of greatest reactivity to treatments. In performing thisfunction, therefore, one or more grid-like areas may be defined, andused as potential sites for the application of one or more treatments.

Accordingly, the set-point page may include one or more additionalparameters for defining one or more grids, which grid may be used todetermine the targeting area, e.g., by use of a first grid, and once thetargeting area has been determined, this area may be used to determinetreatment area by which determination, e.g., by use of a second grid,one or more treatment sites may be defined. Additionally, a calibrationand/or treatment time can also be set, such as to define the time periodthe tMS device will apply a magnetic pulse to a target and/or treatmentregion, such as to calibrate the device and/or treatment methodology.

As can be seen with respect to FIG. 6D, both the first grid, e.g., usedto define the target area, and the second grid, e.g., used to define thetreatment area, may have a dimensionality that may be adjustablyselected at the GUI. Particularly, an operator of the system caninitiate a first pass target and/or calibration selection protocol fromthe GUI, which will then start a first pass of testing, as exemplifiedin FIGS. 5A and 5B, so as to determine the best target site selections.Calibration treatment times and target coil distances may also beadjustably selected. As indicated, in this instance, the grid may firstbe composed of relatively larger boxes having lengths and widths ofabout 3 mm, 4 mm, 5 mm, 6 mm, 10 mm, 20 mm, and the like. So as todetermine potential target sites.

Then, as depicted in FIG. 5C, one or more targeted sites may be selectedfor further targeting analysis, where the selected target site now formsa treatment area, which itself may form a grid where each box has anarea of 1 mm×1 mm. Hence, upon the operator's selection of the best,e.g., most reactive, target sites, in this instance area 4, the selectedtarget site may then be separated into a sub-grid representing, in thisinstance, 1-9 different potential treatment areas. Consequently, asdepicted in FIGS. 5C and 5D, once the secondary grid, e.g., sub-grid,has been selected and formatted, the targeting sequence can be repeated,such as by repositioning the tMS device to a new start position for thesecond pass and restarting the sequence in the selected target site,e.g., 1, and progressing the device through the newly defined treatmentareas 1-9, so as to better determine one or more particular treatmentsites, e.g., treatment site 6, which site, once identified, can beselected as one or more therapy treatment sites.

For instance, as discussed above, during these procedures, thepositioning element, such as the robotic arm and/or the tMS device, canbe moved manually by the operator, or automatically by the system, suchas based on one or more predetermined parameters, such as where thesystem determines the parameters to be implemented in accordance withthe various calculations that are employed to determine the optimaldevice positioning, orientation, treatment parameters, and/orconfigurations. In various instances, the GUI may present an interactiveinterface, e.g., including toggles, that may be manipulated by theoperator to move the positioning element and/or tMS device. Forinstance, a set of X, Y, and Z toggles may be presented for moving thepositioning element and/or tMS device sideways in a horizontaldirection, upwards and downwards in a vertical direction, anddiagonally, respectively. Toggles for rotating the components of thesystem, e.g., about an X, Y, and Z axis, may also be provided.

Accordingly, once a first pass has been performed, e.g., manually orautomatically, then a second pass may be performed, such as where thepositioning element and/or tMS device, including the magnetic inductionelement, may be moved into a starting position, such as at one gridlocation, e.g., represented by area 1 of FIG. 4, and then a newtargeting procedure may be implemented, as per above, where thepositioning element and/or tMS device is moved from one location, e.g.,1, to another, e.g., sequentially, so as to determine the appropriatetreatment areas, from which one or more treatment sites may bedetermined.

Once this second pass has been performed, the operator or work flowmanagement system, e.g., controller, can then initiate treatments at theselected treatment site, such as by selecting the starting area forinitial therapeutic delivery of the magnetic pulse. In this manner, thepositioning element may manually or automatically move the coil to thetreatment starting position, and once the treatment region has beendefined, one or more treatment markers, e.g., reflective or lightingelements, may be positioned proximate the determined treatment sites,and treatment may be delivered to the selected areas composing theindividual treatment sites.

At any time, but particularly after the target area has been defined, acalibration protocol can be initiated, whereby the distance, time,duration, frequency, pulse intensity, amplitude, wavelength, and/orother device and treatment parameters may be determined. Any one ofthese dimensionalities can be selected and modulated such as at a systeminterface presented at a display associated with the control unit, e.g.,stand alone computer, of the system. For instance, as set forth at FIG.6D, the system may include programming that is configured for generatinga graphical user interface (GUI), such as for selecting and setting thevarious system parameters, and or for running one or more treatmentprotocols and/or a positioning sequence and/or calibration process.

Specifically, in a first instance, the dimensionality of a first and asecond grid area may be defined, see FIG. 6C, such as by entering at theGUI interface a desired length and/or width of the target area, so as todefine an initial target area, from which the dimensionality of a secondgrid area, e.g., a treatment area, may then be defined. Further, thecharacteristics of the positioning procedure and/or a calibrationprocess may be selected from the GUI. For example, an initial generalmagnetic flux, e.g., treatment, application time and/or coil to targetdistance can be selected or otherwise entered into the system, wherebythe initial distance that the positioning element may hold the tMSdevice, and/or magnetic coil, away from the target area, and the lengthof time the device is to be held at that position may be determined.

These initial parameters may be selected as a first set of grossoperational bounds, so as to calibrate appropriate coil to targetdistance, and/or to determine the appropriate treatment time periods.Accordingly, when running a calibration and/or positioning procedure, atreatment time, duration, and/or set point can be selected, e.g., via adrop down menu or via entering required text in accordance with a textbox prompt, and the like. Particularly, the calibration treatment timemay be selected so as to specify the time the coil will be maintained ateach location as it moves sequentially from one grid location toanother, such as prior to moving to the next grid location in thesequence. This procedure may be repeated a number of times, through oneor more passes, e.g., 2, 3, 4, or more, in a manner so as to determinethe appropriate positions that compose the treatment site, as well, asthe device treatment delivery parameters.

Additionally, as set forth in FIG. 6D, a system operator, or a suitablyconfigured A/I module of the system, may determine or otherwiseimplement a tracking procedure, which tracking procedure sets the boundswithin which the targeting and/or treatment procedures may beimplemented. For instance, the operator of the system may set a firstset of parameters, such as for determining a target area within which atreatment operation may be performed, such as within which the imagingcomponent may track the movements of the positioning element and/or tMSdevice. For example, a tracking pattern may be configured such as by theoperator entering, and/or the system automatically determining, theparameters for performing a targeting procedure, from which procedures aset of parameters for running a treatment procedure may be determined.

Particularly, when configured for manual selection, the user interfacemay present a number of parameter dimensions that are to be selected orotherwise chosen by the operator, such as by entering the determinedvalue into a text prompt. These parameters may include a minimum andmaximum value (or range) for one or more of: a tracking region, atreatment region, a tracking movement time, a treatment movement time,number movements, a tracking and/or treatment distance, positioningcoordinates, target and/or treatment area coordinates, and the like. Forexample, FIGS. 7A-7B, present a GUI for performing a tracking procedure.Particularly, although this may be performed automatically by thesystem, in various embodiments, this may be performed, or at leastinitiated, manually, such as by deselecting a tracking protocol at theGUI.

More particularly, as shown in FIG. 7A, a tracking accuracy progressscreen is depicted, in this instance evidencing a misalignment. Themisalignment can be illustrated in any suitable form, but in thisinstance, it is demarcated by a target alignment illustrated by a darkdot, and the actually alignment, which is illustrated by an open circle.As can be seen with respect to FIG. 7A, the open circle of the actualalignment is offset from the dark dot representing the target alignment.However, as set forth in FIG. 7B, the open circle overlaps the targeteddark dot, thereby indicating that the actual alignment coincides withthe targeted alignment. Hence, when a misalignment occurs, asexemplified in FIG. 7A, a new alignment protocol may be implemented soas to ensure the proper targeting alignment has been procured, eithermanually or automatically by the system. Accordingly, the GUI candisplay tracking and alignment accuracies, which may be displayedgraphically and or descriptively by one or more texts boxes, such as atext box indicating a degree of tracking, alignment, and/or distancewith respect to an optimal targeted alignment.

Additionally, as can be seen with respect to FIG. 6D, along with thetracking settings, the distance sensor settings may also be determined,for instance, a sensor “on”/“off” button may be deselected, which whenselected will allow for selecting the parameters for configuring thedistance sensor parameters. For example, where the system sensorsincorporate a time of flight module and/or torque-force sensor, theoperational parameters for these sensors may be entered into the system,such as the TOF offset, and/or the force threshold and force retreatdistance may be entered. Specifically, the torque force sensor may beconfigured for retracting and withdrawing the positioning element and/ortMS device if a treatment subject makes contact with one of the devicecomponents, such as accidentally, such as where such contact can causeharm or pain to the subject. However, by setting a minimal contactforce, when such a force is encountered, the devices of the system maybe automatically withdrawn automatically.

Additionally, with respect to the imaging component and/or a distancesensor, a determined distance configuration can be entered into thesystem, e.g., at the GUI, such as for automatically positioning thepositioning element and/or tMS device into a predeterminedconfiguration, and/or the GUI can give real-time feed back of thepresent position of the positioning element and/or the tMS device, suchas via real-time, time-of-flight sensing. The network setting andcommunications protocols can also be adjusted via the presented GUI.Accordingly, the system may be configured for real-time targeting andtracking of the targeting and treatment space as well as the movementsof the positioning element and tMS devices within that space.

For instance, once one or more treatment areas have been defined thesystem itself, or an operator, can initiate a therapy session where oneor more magnetic pulses may be applied to the treatment area/site suchas for the alleviation of pain thereby. In particular instances, theapplication of the therapy may be conducted with target area tracking,and may continue until complete, paused, or stopped by the operator, orif there is an unexpected contact between the subject being treated anda device of the system. During treatment the system may be configured tomonitor positioning of the positioning element and/or tMS device withrespect to the target and/or treatment area marker element(s) positions,particularly, as with respect to a primary and/or a secondary markerplaced proximate the target and/or treatment areas. Such positioning maybe monitored and/or tracked via the imaging component, e.g., camera,and/or the distance sensor, e.g., the time-of-flight sensor, whichmonitoring and/or tracking may allow the system controller to receiveand process this data to monitor and track any patient position changes,and in view of which to calculate new target position values. Likewise,in light of the new positioning calculations, the controller can thendirect the movements of the positioning element and/or tMS device to thenew target positions thereby tracking the target and/or treatment areas.

Accordingly, the system can be configured so as to provide feedback toand between the various components of the system, such as between thepositioning element, tMS device, the imaging component, the distancemeasuring sensor, the control unit, and the like. If at any giveninstance the position feedback is lost the positioning element may thenstop treatment and/or maintain the current position and/or return to thelast tracked location. This may occur in an instance where the primarytracking marker element loses connectivity with the distance scanner. Insuch an instance, the last known position values of the primary and/orsecondary marking devices may then be used to re-initiate and/orcontinue target and treatment area tracking. For instance, the secondarymarker can be employed to continue the tracking, and once connectivitywith the primary marker becomes available again the positioning elementmay once again be stopped at its current location, and/or restarted oncefull connectivity has been reestablished. Then the position markingelements of the primary marking device may be used again for positiontracking.

Particularly, in view of the above, FIG. 8 presents a methodology forperforming a targeting and/or treatment procedure. For instance, FIG. 8Apresents a start screen at a graphical user interface for theimplementation of one or more procedures of the system, including aninterface for moving the system components to a home or targeted, e.g.,a previously determined target, position, a calibration interface, suchas for calibrating an imaging element, e.g., a camera, with thepositioning element, e.g., a robotic arm, and/or a target and/ortreatment region. A start or a complete interface may also be provided.Specifically, by engaging the home or targeted interface, the variouscomponents of the system may be retracted from any position they are inso as to return to a home position, of they may be moved from a startingposition, e.g., a home position, and be moved into a pre-definedtargeted position, respectively.

Likewise, as set forth in FIG. 8B, if a calibration interface isengaged, a targeting procedure may be implemented, as described above,wherein a virtual representation of a target area may be generated andapplied, such as in a virtual manner, to the target area. Specifically,as can be seen with respect to FIGS. 8B-8C, the system may be configuredfor generating and/or displaying a target area, such as near the regionto be treated, or as a virtual representation of the target areapresented at the graphical user interface of the display, as exemplifiedby FIG. 8D. For instance, as exemplified in FIG. 8B, a target area maybe projected onto a body part of the patient, e.g., the arm, such aswhere, in this instance, the projection is configured as athree-dimensional axis, such as including an X-axis, a Y-axis, and aZ-axis, which axes can be used to define the target area, and from therethe treatment area may be determined.

Particularly, in various instances, once a target area is definedgenerally, a treatment area may then be defined. For example, in aparticular embodiment, a grid-matrix may be generated and, in someembodiments, may be projected onto the body part to be treated, so as toprovide a framework within which a targeted area may be tested so as todetermine its amenability, e.g., reactivity, for treatment. Morespecifically, as discussed above each box in the grid represents an areato be tested, such as in an iterative process by moving the tMS devicein a manner to deliver one or more magnetic impulses to each of thedemarcated areas, e.g., 1-9, so as to determine the reactivity of eacharea to the magnetic treatments, whereby each area that is determined tobe reactivity represents and/or otherwise defines one or more treatmentsites. As can be seen with respect to FIGS. 8C and 8D, the target siterepresented by area 5 is reactive to the treatment, and thus, can besubjected to further testing to define one or more particular treatmentsites.

In particular instances, the projected grid matrix, as illustrated inFIG. 8C, may be modeled virtually at the graphical user interface, asillustrated in FIG. 8D. However, in other instances, the projected gridmatrix need not be used, rather, only the virtual matrix need bepresented for performing the targeting procedures. More particularly, asrepresented in FIG. 8E, once a treatment area has been determined, inthis instance area 5, e.g., so as to define the X and Y planes of thetreatment area, such as in a first and second pass, a further pass maythen be implemented so as to determine the Y-axis dimension of thetreatment site, such as to determine the depth for the treatmentapplication. Accordingly, once a treatment site has been determined andits dimensionality defined, such as with respect to its X, Y, and Zcoordinates, then the positioning element and tMS device may be alignedto the treatment site, and the alignment procedure may be completed,such as exemplified in FIG. 8F, where the treatment alignment is shownto correspond to the target alignment.

It is to be noted that in various instances, a system fault orinterruption may occur, such as if an unintended contact occurs betweenthe tMS device and/or positioning element and the treatment site. Uponsuch an occurrence, e.g., of a system fault, the tMS device will stopapplying a magnetic field, and/or the positioning element will retract,and the current sequence/operation will be aborted. In such an instance,the fault condition may be removed and the fault message may beacknowledged by the operator. Each sequence may then be restarted. Anemergency stop may also be implemented manually by the operator or thesubject receiving treatment.

In various instances, the system may include an artificial intelligence(A/I) module that may include a learning or training platform that isconfigured for collecting and/or otherwise receiving data, e.g.,pertaining to a collection of treatments of a single or multiplesubjects, aggregating and/or compiling data, and then processing thedata for the purposes of one or more of: learning the voice and words orphrases of a user, such as an operator and/or subject to be treated,learning the optimal treatment conditions, including positioning andorientation for efficient and effective delivery, and/or learningoptimal administration parameters, such as regards the strength,frequency, amplitude, depth, duration, and/or other wave qualitycharacteristics for modulating the magnetic pulse to be delivered to thesubject for treatment. For instance, as described above, in variousinstances, the system may be configured for being operated manually,such as by a trained operator, whereby the system assist the operator inthe performance of their operation of the system. However, in otherinstances, the system may be adapted for being configured and/oroperated autonomously and/or automatically, such as by the subject to betreated, e.g., for individual home use. In either instance, the systemmay be configured for receiving a voice command, e.g., one or moreinstructions with regard to the administration of a treatment, and thenperforming that treatment in response the received instructions.

Additionally, the system may further include an inference engine that isconfigured for: predicting one or more of the meaning behind the wordsand/or phrases employed by users, especially with respect to their useof the system to orientate the device and perform a treatment; todevelop one or more set of rules or instructions based on an analysis ofthe collected data with respect to pain experiences and systemconfigurations for the effective and efficient administrations oftreatment; and/or for analyzing user feedback so as to learnindividualized treatment parameters in order to make treatmentpersonalized to the subject to be treated.

As such, the system is capable of receiving voice or other enteredcommands and/or use parameters from a plurality of users and patientswith regard to their receipt of treatments. In particular instances, asindicated above, the system may include a downloadable app that iscapable of being downloaded and/or otherwise installed on a user device,e.g., a desktop, laptop, or other mobile computing device that may be asmart phone or computing watch. For example, a computing deviceconfigured as a mobile phone, or a wrist-worn watch may be provided,where the mobile device includes a display screen upon which a graphicaluser interface of the system may be presented. The voice command may bein natural language, while computer derived commands may be in acomputer language implemented in the system.

Upon receiving a voice or other command, such as an instructionpertaining to the configuration of the system and/or to receiving atreatment thereby, the system, via an associated controller and/or themobile computing device, may then transmit the voice command to thecentral server of the system, particularly to the A/I module of thesystem. The A/I module may be configured to include a voice recognitionand/or modulation module that is capable of receiving and determiningthe meaning behind a user's voice and/or other entered commands, and maythen initiate one or more routines within the system to effectuate theusers command, such as with respect to effectuating the configuration ofthe system and/or the administration of treatments. The voice dataand/or other user entered commands may be received and/or entered intothe system via a suitably configured application programming interface,API. Once received by the system, the command may be interpreted by thesystem, e.g., a speech recognition application, whereby the languagewill be parsed, and relevant data, e.g., configuration data and/ortreatment delivery data, may be entered into the system. The system maythen forward a confirmatory message back to the device of the user so asto allow the user to confirm that the system has correctly interpretedthe voice or other commands.

For example, the system may automatically determine the relationshipsbetween different users and their preferences and habits, e.g., withrespect to their receipt of treatments, and in turn the system candetermine the same for other users experiencing the same or similar painat the same or similar locus, such as due to the same or similar nervedamage. Accordingly, the system may include a searchable database thatanonymizes patient data, but then allows the treatment parameters anduser feedback data to be searched by the system and be employed therebyto determine one or more trends and/or usage factors that may beimplemented in developing personalized or universal rules for deliveringof treatment to one or more subjects. Accordingly, the ArtificialIntelligence Module may be used to gather and/or harvest collected dataabout users and their experience of pain and their treatment parameters,which information may be employed by the system to make predictions,suggestions, and/or weight, and/or adjust potential usages of the systemby the user with respect to the pain they experience and treatments theyreceive in response thereto. This data may be collected by the systemand may be fed into the A/I module, e.g., a machine learning platform,and may then be used as data points to form and/or structure asearchable database of the system.

In this manner, all of the treatments, e.g., pain experience, painlocation, and treatment configurations, implemented by users of thesystem, and their usage patterns may be collected and analyzed by thesystem so as to determine useful patterns of treatments and painalleviation to better assist the treatment needs and/or patterns of itsusers, in general, or specific to any given particular user. Oncecollected, the data may then be structured into a table or graph, orother relational infrastructure, such as a hash table or data tree orknowledge graph that may then be used to identify correlations and/orrelationships between the data, such as between pain experience and/orlocation and treatment parameters and/or system configurations.

Such relationships may then be weighted and mined to determinecorrelations between those experiencing, or not experiencing painamelioration, the treatment parameters and configurations that have led,or not led, to that amelioration, the treatment sites andconfigurations, as well as various other subject related factors thatmay be relevant to the effectiveness of treatments, such as othermedical or physiological conditions the subject may have, such asexemplified by their genetic code and/or their electronic medical orpersonal health records, and the like. This data may then be fed into anartificial intelligence engine of the system to determine and/or predictpatterns in treatment parameters, configurations, and effectiveness oftreatments. Additional information may also be collected and used tounderstand, evaluate, and characterize subject and/or usage patterns,make predictions and/or suggestions about treatments and configurations,as well as timing and length or duration of treatments. These analysesallows for a great quantity of data to be collected and analyzed so asto derive one or more conclusions, such as a conclusion as related totreatment parameters.

For instance, the A/I component may include an analytics engine that maybe configured for performing both a learning function, such as throughreview of historic data, and to generate rules by which to determinepositioning, configuration, and treatment parameters and/or predictfuture treatment effectiveness patterns. As indicated above, oncecollected, the data may be searched, and may be run through a suitablyconfigured analytics module, such as an artificial intelligence engine,to identify treatment parameters, device configurations andorientations, and pain experience factors from various different sourcesthat may be in some way correlated with one another, and therefore, maybe used to predict effective treatment parameters, such as on a personalor global basis.

Particularly, the data from all various sources may be collected andorganized in a structure that is specifically designed to pinpointcorrelations between otherwise unknown relationships. Such a relationalarchitecture may take many forms, such as in the form of a StructuredQuery Language (SQL), Hierarchical Tree, or Knowledge Graph database.Collected information, for example, may be run through one or morecomputational and/or analytics regimes, as herein described, so as toidentify pertinent known or inferred data points from which variousrelationships between producers, consumers, and delivery agents engagedwith the system may be determined, and motifs in their usage may beexplored, and future patterns predicted.

Accordingly, in one aspect, presented herein is a system including aninteractive, communication platform that is adaptable so as to providefor real-time pain characterization and/or treatment regimes that isconstantly kept up to date, moment by moment, by a server network of thesystem. In particular embodiments, the platform may include one or more,e.g., a plurality, of client application programs, e.g., controlling oneor more treatment apparatuses, such as a disperse network of devicecomputing controllers, which controllers may be in communication with anationwide server or bank of servers, through which the clientapplications the various devices of the system may communicate with oneanother and/or the system. The system may also include one or more of ananalytics module, for performing data analysis; and an artificialintelligence module, for generating a searchable data structure, e.g., aknowledge graph, through which data may be correlated, relationshipsdetermined or inferred, and future behaviors, e.g., subject response totreatments, may be predicted.

Hence, an important aspect of the system is an Artificial Intelligence(A/I) module having one or more of a learning or training platform,including a learning engine, and an analytics or inference platform,including an inference engine. In one instance, the learning platformincludes a processing engine that is configured for taking known data,e.g. device use parameters and/or treatment results data, running alearning and/or training protocol on the data, and developing one ormore organizing rules therefrom. Likewise, the analytics processingplatform includes a processing, e.g., inference, engine that isconfigured for applying the rules developed by or for the learningplatform and applying them to newly or previously acquired data togenerate one or more outcomes thereby, such as where the outcome may bea known or inferred relationship, a known or predicted result, and/or aprobability of one or more outcomes, and the like. In various instances,the inference engine is configured for continuously running analytics onreceived data on a daily basis and/or with regard to one or moretreatment regimes.

As indicated above, in one particular embodiment, the A/I module isconfigured for determining correlations between the various datacollected by the system. For instance, in various instances, the A/Imodule may be configured for generating a data structure, e.g., aknowledge graph, wherein the various data collected by the system, e.g.,treatment configurations, device orientations, pain locations, etc., areuploaded into the graph as a constellation of data points. In such aninstance, the learning engine may be configured for taking known rulesto determine known relationships between the known data points, and fromthese known data, the learning engine may be configured for inferringunknown relationships between data points to determine heretoforeunknown relationships between the data points, which in turn may be usedto determine new rules by which to determine other unknown data points,relationships between the two, and/or to make one or more predictiveoutcomes, e.g., effectiveness of a treatment regime, based on the knownand/or learned data, such as in response to one or more queries. Forexample, the data, the relationships between the data, and thedetermined and/or inferred rules may be employed to generate a datastructure, such as a knowledge graph, and/or to mine the various datawithin the system to generate an answer to a query and/or a suggestion,e.g., of the effectiveness of a treatment parameter. Accordingly, aunique feature of the A/I module is its predictive functionality, whichfunctionality may be implemented by a predictive analytics platform thatis configured for performing one or more predictive analyses on theobtained and/or generated data, such as by generating one or morepredictive outcomes.

Further, once determined, the system, e.g., via the suitably configuredlearning platform, may be adapted to configure or suggest deviceconfigurations for treatments of subjects experiencing the same orsimilar pain, such as by the artificial intelligence module increasingor decreasing a weighting scale used to weight the connections betweenvarious influencing factors and user actions and/or outcomes of thoseactions, such as where various treatment parameters are identified withtreatment effectiveness based on subjects experiencing the same orsimilar amelioration of pain with the same or similar systemconfiguration. For instance, in such instances, when various patternsare formed, the system may learn these patterns, determine the presenceof one or more trends, or other factors of import, and/or predict alikely manner in which the user will behave in response to treatments,and the level of confidence may be given to the predicted outcome, suchas from 0.0, not very likely to 1.0 almost completely certain.Accordingly, when the system makes a correct prediction, the connectionbetween the initiating action and the presence of a trend in thataction, as well as the connection between the action and a predictedoutcome of that action, may be strengthened, such as by giving anestimation of the presence of a trend and/or a predicted outcome in thefuture, for the same or substantially similar circumstances, moreweight. In a manner such as this, the system may be configured to keeptrack of the various patients being treated by the system so that thevarious identified factors that may be influencing the emergence and/ormaintenance of such patterns may be identified, predicted, and employedfor determining treatment parameters and configurations for thetreatment of other patients seeking pain relief.

Specifically, the system may generate and employ one or more datastructures that may be queried so as to predict the answer to one ormore questions. For instance, as described in detail herein, the systemmay be configured for receiving and analyzing information with regard toa plurality of patients being treated, which information may include acharacterization of the experience of pain, site of pain, morphology oftreatment site, effectiveness of treatments, and/or configurations andorientations of the system pertaining thereto, which data once collectedmay be incorporated into a data structure of the A/I module. For thesepurposes, the system may present one or more subjects and/or operators aseries of questions, such as via an automated interview process, theresponses to which may be used to characterize the subject's response totreatment. Additionally, the system may automatically track how thesubject responds to the treatments administered by the system, as wellas the attendant data pertaining thereto, such as data related to deviceconfiguration and/or orientation, and treatment parameters, such astime, duration, strength, amplitude, frequency, and other parameterscharacterizing the magnetic pulse being delivered during treatment. Allof this information may form data points that characterize any givensubject of treatment and/or their experience of pain, and response totreatment.

These data points may then be employed as branches or nodes within adata structure, which data structure may take any suitable form, such asa data tree and/or a knowledge graph. From these various data pointsrelationships between subjects being treated may be identified, and theconnections between them may be weighted based on the number and form ofthe interactions between them. Hence, the more subjects respond to thetreatments and/or system configurations with respect thereto, thegreater the weighting will be between the various nodes that may beemployed to define their interaction. Likewise, the more negativelysubjects respond to treatments and/or system configurations with respecttheir to, the less (or more negative) weight will be given to definetheir interactions.

Accordingly, in a manner such as this, data points between the variousbranches or nodes in the data structure of the system may be used togenerate correlations between the nodes and to weight those correlationsso as to build a data structure thereby, such as a knowledge tree orgraph, which may then be queried to determine other relationships notpreviously known and/or to predict the influence of external factorsaffecting the usage of the system, and/or to predict and weightpotential outcomes based on a collective of usage patterns of how usersare engaging with the system. For instance, a data structure, such as arelational or hierarchical or knowledge graph structure, may begenerated by the system receiving known data about the various users ofthe system, e.g., producers or sellers, purchasers of goods, promotionalevent organizers, or other users of the system, and, via a suitablyconfigured data management system, building a structure, e.g., a tree orconstellation, of data points and drawing connections between the datapoints.

For example, the data to be entered into the database, may be used tostructure and populate an inference engine, e.g., based on the graph,which engine may be employed for searching and/or otherwise performingqueries, and may further be utilized by an artificial intelligenceanalytics engine for predicting outcomes and/or making suggestions as tosystem and/or device configurations. Consequently, subject and/ortreatment configuration and/or effectiveness data may be obtained andentered into the system in a variety of different manners, and mayinclude the storing of information in hierarchical or relational models,as well as in a resource description framework (RDF) file or graph, andthe like. Such a procedure may be performed for a number of differentusers.

Accordingly, once generated, the data structure, e.g., knowledge graph,may then be queried along a number of lines so as to make one or moredeterminations with respect to the various relationships between thevarious branches or nodes of the graph. For instance, the system may beconfigured to automatically be queried to determine if there is apattern by which one or more subjects are responding to the treatmentsin the same or similar, such as with respect to system and/or devicesthereof being configured in the same or similar manner. Hence, invarious embodiments, the system may be configured so as to be queriedalong a number of different parameters to determine and weight a numberof different answers, and thereby make a variety of differentpredictions. These predictions may then be given a weighted score, suchas to the probability of being correct, and based on that score, thesystem can self-correct so as to properly account and/or correct for thepredicted response to treatments for those being or to be treated.

In a typical architecture for performing such functions, such as forperforming a structured search query, for instance, the system mayinclude a database. The database may include information pertaining tothe detailed pain experience, site of pain, target and/or treatmentsite, system configurations, device orientations, treatment regimes, andthe like. The database may also include characteristic data pertainingto the patients themselves, and/or relational data pertaining to theirresponse to treatments. In such an instance, the relevant data pointsmay be identified and pulled from the general database, and a localizedor global data structure may be built.

Any data structure may be employed for performing the search inquestion, in various instances, however, the data structure may be arelational data structure, such as a Structured Query Language (SQL)database, which may be implemented via a relational database managementsystem, or the data structure may be a hierarchical, or graph based datastructure. For instance, in one implementation, a SQL database ispresented, which database may be a table based data structure, such aswhere one or more tables form the base structure wherein data may beorganized and stored, such as in a variety of columns and rows,searched, relations determined, and queries answered in a structuredmanner. Particularly, in such an instance, SQL statements may be used tostructure, update, and search the database.

In various embodiments, a table-based database may be presented, e.g., arelational database structure, which data structure may be searched, andused to determine relationships from which answers to one or morequeries may be determined. Typically, in such a data structure,identifiers, such as keys, are used to relate data in one table to thatin another table. Accordingly, provided herein is a database that may bebuilt and structured as a structured query language (SQL) database thathas a relational architecture, and may be managed by a data managementsystem, such as a relational database management system (RDBMS). Inparticular instances, a series of tables, for instance, may be employedby which correlations may be made in an iterative fashion.

Accordingly, a key, such as an electronic medical record identifier, maybe used to correlate the tables, which key may be accessed in responseto a question, prompt, or command, such as how the patient is respondingto treatment administered by the system when the system is in aparticular configuration, and/or how that response changes when thesystem configuration changes. In various instances, the key may be anycommon identifier or an encrypted identifier employed to keep thesubject's identity private. Accordingly, without the key it becomes moredifficult to build correlations between the information in one tablewith that of another. In certain instances, the table may be a hashtable and a hash function may be employed in search the table forcorrelations with other data structures.

A further architecture that may be used to structure a database is ahierarchical data structure. For instance, in various instances, thedatabase may be structured as a data tree, e.g., a suffix or prefixtree, where various data elements may be stored in a compressed, but incorrelated fashion, where the various roots and branches form divergentdata points with respect to potential correlations. Specifically, insuch an instance, the data may be stored within the data structure insuch a manner that the stored records are connected with one anotherthrough relational links, such as where the various records are acollection of fields that store data files in a chain of superior andsubordinate levels of organization, such as in a pyramidal or otherhierarchical configuration.

In other instances, a graph-based architecture may be structured andused to determine the results for one or more queries. Particularly, aknowledge graph architecture may be employed to structure the database;so as to enhance the performance of computational analyses executedusing that database. Such analyses may be employed so as to determinewhether a given user's present use of the system comports with theirpast use and/or comports with how other users in general, e.g. theaverage user, have or are presently interacting with the system, such aswith respect to the present user's scoring of a given event and/orperformer in the event, and/or with respect to their regular pattern ofusage.

In a manner such as this all of the treatment protocols, systemconfigurations, device orientations, patient responses to treatment, aswell as patient and operator feedback for one or more subjects, such asfor all subjects being treated, may be organized and stored by thesystem in a dedicated database, such as a health management database,wherein the data to be stored may be tagged, characterized, grouped intoone or more categories, e.g., based on pain experience, and may then bestored in a structured architecture as described above. Specifically, invarious instances, the treatments and patient feedback being trackedwithin the system, as well as all the various data associated with thetreatments may be tracked by any suitable tracking system, but in someinstances, may be tracked by a suitably configured block-chainmechanism.

An additional feature of the system is that it provides a morepersonalized health management experience for the subject being treated.For instance, the system may track patient pain experience and responseto treatments, and may as well track their other health and/or dietarycharacteristics, and/or may track other patient experiences having asimilar or same experience. Such tracking may be performed throughoutthe system, trends with regard to treatment effectiveness may beidentified, and the system may then make suggestions to the operatorsand/or patients receiving treatment based on previously administeredtreatment regimes that have been shown to be effective in the treatmentof others having the same or similar characteristics of their painexperience. For example, the system may track and analyze all relevantinformation regarding the patients experiences of pain and the systemconfigurations that have led to a decrease in pain experience for thosesubjects, and can make treatment suggestions based on the system'sanalysis of the collective of patients being treated, their painexperiences, their pain locations, and their responses to treatments, aswell as the configurations of the system and devices thereof withrespect to those treatments administered.

In particular instances, to facilitate one or more of theseimplementations, a software and/or hardware application may be presentand executed by one or more of the system controlling and/or treatmentdevices and may provide a user interface that can display informationfrom or about a subject to be treated and/or device configurationsand/or status monitoring device(s) and/or the control device. Theinterface may further provide input portions that permit the user toenter information and/or commands. For instance, such a softwareapplication may be in the form of a “mobile app” for use on or executionby a mobile smartphone or dedicated device or processor thereof, or maybe in the form of a software application for execution in a conventionalpersonal computer (e.g., desktop or laptop or tablet) or enterprisecomputer system.

For instance, an exemplary software application may present a user witha one or more menus or screens configured at least for permittingviewing and/or selection of user preferences or settings, for viewingdata received from or related to one or more treatment modalities and/orsystem component configurations and for controlling said functionsand/or determining the positioning of the various components of thesystem. In addition to such control and presentation of wireless (orwired) communications, communication features may include transmissionof commands and settings, receipt of sensor data, feedback data, and/orhistorical use data, alarm/warning notifications (e.g., at loss orattainment of proximity), etc., all of which may be collected by thesystem, be stored within a database, and be retrieved and analyzed bythe system to suggest future use protocols.

Hence, in various instances, implementations of various aspects of thedisclosure may include, but are not limited to: apparatuses, systems,and methods including one or more features as described in detailherein, as well as articles that comprise a tangibly embodiedmachine-readable medium operable to cause one or more machines (e.g.,computers, etc.) to result in operations described herein. Similarly,computer systems are also described that may include one or moreprocessors and/or one or more memories coupled to the one or moreprocessors. Accordingly, computer implemented methods consistent withone or more implementations of the current subject matter can beimplemented by one or more data processors residing in a singlecomputing system or multiple computing systems containing multiplecomputers, such as in a computing or supercomputing bank.

Such multiple computing systems can be connected and can exchange dataand/or commands or other instructions or the like via one or moreconnections, including but not limited to a connection over a network(e.g. the Internet, a wireless wide area network, a local area network,a wide area network, a wired network, a physical electricalinterconnect, or the like), via a direct connection between one or moreof the multiple computing systems, etc. A memory, which can include acomputer-readable storage medium, may include, encode, store, or thelike one or more programs that cause one or more processors to performone or more of the operations associated with one or more of thealgorithms described herein.

Any of the features or attributes of the above the above describedembodiments and variations can be used in combination with any of theother features and attributes of the above described embodiments andvariations as desired. From the foregoing disclosure and detaileddescription of certain disclosed embodiments, it is also apparent thatvarious modifications, additions and other alternative embodiments arepossible without departing from the true scope and spirit.

The embodiments discussed were chosen and described to provide the bestillustration of the principles of the present invention and itspractical application to thereby enable one of ordinary skill in the artto utilize the invention in various embodiments and with variousmodifications as are suited to the particular use contemplated.

All such modifications and variations are within the scope of thepresent invention as determined by the appended claims when interpretedin accordance with the benefit to which they are fairly, legally, andequitably entitled.

The methods illustratively described herein may suitably be practiced inthe absence of any element or elements, limitation or limitations, notspecifically disclosed herein. Thus, for example, the terms“comprising”, “including,” containing”, etc. shall be read expansivelyand without limitation. Additionally, the terms and expressions employedherein have been used as terms of description and not of limitation, andthere is no intention in the use of such terms and expressions ofexcluding any equivalents of the features shown and described orportions thereof. It is recognized that various modifications arepossible within the scope of the invention claimed. Thus, it should beunderstood that although the present disclosed embodiments have beenspecifically disclosed by representative configurations and optionalfeatures, modification and variation of the embodiments herein disclosedmay be resorted to by those skilled in the art, and that suchmodifications and variations are considered to be within the scope ofthis disclosure.

Specific embodiments have been described broadly and generically herein.Each of the narrower species and subgeneric groupings falling within thegeneric disclosure also form part of the methods. This includes thegeneric description of the methods with a proviso or negative limitationremoving any subject matter from the genus, regardless of whether or notthe excised material is specifically recited herein.

Other embodiments are within the following claims. In addition, wherefeatures or aspects of the methods are described in terms of Markushgroups, those skilled in the art will recognize that the invention isalso thereby described in terms of any individual member or subgroup ofmembers of the Markush group.

1. A system for delivering transcutaneous magnetic stimulation (tMS) toa treatment site on a body of a subject, the system comprising: a tMSdevice configured for delivering a focused magnetic flux to thetreatment site when positioned proximate the body of the subject, thetMS device comprising: a housing having an extended body, the extendedbody including a proximate portion having a proximate end, and a distalportion having a distal end, the extended body defining a cavity forretaining one or more components of the tMS device; an insulatedmagnetic coil disposed within the proximate portion of the extended bodyof the housing, the magnetic coil configured for generating anddelivering a focused magnetic flux at a determined pulse rate; and acontrol module in communication with the magnetic coil, the controlmodule configured to control the focused magnetic flux and the pulserate to be delivered by the magnetic coil of the tMS device so as todeliver tMS to the treatment site of the subject; a positioning elementhaving a proximal portion including a proximal end, and a distal portionincluding a distal end, the distal portion being coupled to the magneticcoil proximate the distal end, the positioning element being composed ofa plurality of articulating arm members, a plurality of the arm membersbeing coupled together by an automating element, the automating elementfor assisting in the positioning of the tMS device proximate thetreatment site; an imaging component, the imaging component includingone or more image capturing devices, each image capturing device beingconfigured for capturing one or more images defining a three-dimensionalspace, the three-dimensional space being occupied by one or more of thesubject, the tMS device, and the positioning element; a distance scannercoupled to the housing of the tMS device, the distance scanner beingconfigured for determining a distance between the magnetic coil and thetreatment site on the body of the subject to be treated; a reflectivemarking device for being positioned proximate the treatment site, thereflective marking device including a plurality of reflective elementsconfigured for reflecting back a light emitted from the distance scannerin a manner sufficient for enabling the distance scanner to determinethe distance between the magnetic coil and the treatment site; and acontrol module coupled to the proximal portion of the positioningelement near the proximal end, the control module being configured forcontrolling one or more of the tMS device, the positioning element, theimaging component, and the distance scanner.
 2. The system in accordancewith claim 1, wherein the magnetic coil of the tMS device furthercomprises a plurality of coils, the plurality of coils being arranged insuch a manner as to generate a magnetic field between them, thegenerated magnetic field having an amplitude greater than an amplitudethan that which either coil could generate individually by itself. 3.The system in accordance with claim 2, wherein the determined pulse rateof the magnetic flux generated by the tMS device has a frequency withinthe range from about 0.2 Hz to about 5 Hz.
 4. The system in accordancewith claim 1, wherein the automating element comprises one or moremotors, the one or more motors configured for providing movement alongone or more of an x, y, and z, plane.
 5. The system in accordance withclaim 4, wherein the one or more motors configured for providingmovement along one or more of an x, y, and z, axis.
 6. The system inaccordance with claim 5, wherein the positioning element comprises arobotic arm.
 7. The system in accordance with claim 6, wherein thecontrol module is configured to control the one or more motors of therobotic arm in a manner so that the robotic arm moves autonomously. 8.The system in accordance with claim 7, wherein the imaging componentcomprises a camera.
 9. The system in accordance with claim 8, whereinthe camera comprises a stereoscopic camera.
 10. The system in accordancewith claim 9, wherein the distance scanner comprises a laser.
 11. Thesystem in accordance with claim 10, wherein together the stereoscopiccamera and the distance scanner are configured for tracking and aligningthe magnetic coil with respect to the treatment site.
 12. The system inaccordance with claim 11, wherein the tracking and aligning is performedreal-time so as to maintain an optimal distance between the magneticcoil and the treatment site despite any movements of the subject. 13.The system in accordance with claim 12, wherein the reflective markingdevice comprises a plurality of opposed extended arm members, whereineach arm member includes a proximal portion having a proximal end and adistal portion having a distal end, the arm members being coupled to oneanother at their proximal ends, the reflective marking device includinga reflective element positioned proximate the distal end of each armmember.
 14. The system in accordance with claim 13, wherein one or moreof the arm members of the robotic arm comprises a reflective element,the reflective elements facilitating the tracking of the robotic armthrough the three-dimensional space.
 15. The system in accordance withclaim 14, wherein the positioning element comprises a pressure sensorconfigured for retracting one or more of the robotic arm or the magneticcoil.
 16. The system in accordance with claim 15, wherein the pressuresensor comprises a torque-force sensor.
 17. The system in accordancewith claim 16, wherein the system further comprises a cloud based servercoupled to a database, the cloud-based server configured for processingimage data so as to produce results data, and the database for storingone or more of the image data and the results data.
 18. The system inaccordance with claim 17, wherein the control module comprises acommunications module configured for allowing the control module tocommunicate with the cloud-based server over a network connection. 19.The system in accordance with claim 18, wherein the control module isconfigured for implementing one or more instructions, the one or moreinstructions pertaining to positioning the tMS device in an optimalplacement for the delivery of tMS to the treatment site.
 20. The systemin accordance with claim 19, wherein the control module includes acontrol device for displaying a graphical user interface of the system.